Ormco/Sybronendo
Glendora, CA, US
Ormco/Sybronendo appears in FDA device records in Glendora, CA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 27 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 27
- Registered establishments
- 0
FDA records under these names
1 nameFDA records resolved to Ormco/Sybronendo carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Ormco Corporationrecall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
Showing 25 of 27| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1258-2020 | SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months. | Class II | Terminated | |
| Z-1257-2020 | SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only | The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months. | Class II | Terminated | |
| Z-2286-2020 | Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, Tq +13 degrees, Rx. Manufactured by Ormco Corporation, This device is intended for use for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. | The bracket torque was mislabeled on the packaging. | Class II | Terminated | |
| Z-0413-2018 | Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers Device is an endodontic root canal plugger. It is intended to be used in Dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, to backfill and downpack gutta percha during Endodontic root canal treatment, and when in Extruder mode it is used only to backfill gutta percha during root canal obturation. | Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU). | Class II | Terminated | |
| Z-2836-2016 | Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth. | SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11. | Class II | Terminated | |
| Z-1083-2016 | TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a endontontically obturated root canal treatment | Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner generic label is identified as ML3. The products outer package is identified as SM3 which matches the product inside. | Class II | Terminated | |
| Z-0343-2016 | Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement. | Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect. | Class II | Terminated | |
| Z-1321-2014 | Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 449-6212, Lot Number 121359169. A fixed attachment on a tooth which holds an archwire during orthodontic treatment. | Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, Lot Number 121359169, because the color ID dot was marked on the wrong tie-wing of the brackets. | Class II | Terminated | |
| Z-1330-2014 | Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number 081351013. Product Usage: An orthodontic bracket. Spirit MB Brackets are a fixed attachment on a tooth which holds an archwire during orthodontic treatment. | Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 081351013, because the ID dot, which designates the bracket as distal/gingival, is misplaced. The misidentification may lead an orthodontist to place the bracket on the wrong tooth, leading to movement 10 degrees in the wrong direction. | Class II | Terminated | |
| Z-2194-2013 | Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. Vector T AS 8mm Screw is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and removed after orthodontic treatment has been completed. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices. | Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws of this lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. Use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces. | Class II | Terminated | |
| Z-1084-2013 | Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires used to move teeth during orthodontic treatment | Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a packaging error. More specifically, the Bracket Buccal Tubes product package correctly identifies the product as gingival (0) offset brackets, but actually contains distal (10) offset brackets. Use of the affected product may cause unintended rotation of the molars. Although reversible, a delay in | Class II | Terminated | |
| Z-1545-2013 | SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy, Made in Taiwan The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment. | A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord. | Class II | Terminated | |
| Z-1544-2013 | SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S. Lone Hill Ave. Glendora, CA 91740; EU Rep: Kerr Italia, S.r.l, Via Passanti, 332, 1-84018 Scafati (SA), Italy The intended use of the Elements Obturation Unit and Replacement A/C Power Cord is to provide continuous heat at the tip of the dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation and to backfill and down pack gutta percha during endodontic root canal treatment. | A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Unit and its Replacement A/C Power Cord. | Class II | Terminated | |
| Z-0765-2013 | Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal. | The length markings on the Lightspeed LSX files were wrong. | Class II | Terminated | |
| Z-0120-2013 | The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment. | The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets. | Class III | Terminated | |
| Z-0205-2013 | Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. | The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization temperature should be listed as 132C and/or 270F. | Class II | Terminated | |
| Z-0201-2012 | Spirit MB Brackets, part #494-1211. The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment. | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. | Terminated | ||
| Z-0200-2012 | Spirit MB Brackets, part #494-1210. The brand name of the device is Spirit MB Brackets, an orthodontic bracket. Spirit MB Brackets have been assigned the product code 76 DYW (Plastic Orthodontic Bracket) by the FDA and is classified as a Class II Medical Device. Spirit MB Brackets are to be fixed attachment on a tooth which holds an archwire during orthodontic treatment. | Ormco Corporation is voluntarily recalling three lots of Spirit MB Brackets due to a manufacturing error. | Terminated | ||
| Z-0639-2012 | TMA Archwires, Part Number 211-1402, Lot Number 10K291, Product Description and Intended Use: The intended use of this device is an archwire during orthodontic treatment. | The TMA Lower Broad Arch packages labeled with part number 211-1402 actually contained TMA Upper Archwires, part number 2021007. | Terminated | ||
| Z-0160-2012 | Microseal Master Cone Part Number: 815-9033 Microseal Master Cone is intended to obturate root canals during endodontic therapy procedures. | The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled. | Terminated | ||
| Z-1148-2012 | AdvanSync is an orthodontic device intended for the orthodontic treatment of Class II malocclusions. The AdvanSync part numbers and lot numbers affected by this recall are as follows: Part Number: 600-4000 (Kits-include 10 Right 600-4000 and 10 Left Assemblies). Lot Numbers: 070990588, 070976869, 060971515, 060971514, 04094278D Part Number: 600-4040 (5-Pack, Left Assembly). Lot Numbers: 080901333, 080902356, 070981416, 060971299, 060976084 Part Number: 600-4041 (5-Pack, Right Assembly). Lot Numbers: 080902357, 080901335, 070981417, 060971304, 060976079 | Manufacturing Error: There is a potential for a braze joint failure in the upper telescopic rod assembly. Although an incident could occur in which the eyelet loses connection from the rod, there is no risk of swallowing or aspirating the appliance because it will still be attached to the patient's crown. | Terminated | ||
| Z-1136-2012 | Brand name: Orthos CM Bracket, Orthodontic Metal Bracket, Part Numbers: 454-1210, 454-0210. The intended use of this device is a fixed attachment on a tooth which holds an archwire during orthodontic treatment. | The recall was initiated because Ormco has confirmed that manufacturing error resulted in the Orthos CM Brackets being incorrectly manufactured with a torque of -9. The packaging was labeled with +9 torque; however the brackets contained inside the packaging are actually Orthos CM Brackets with a torque of -9. | Terminated | ||
| Z-1172-2012 | K3 Engine File G-Pack, Product: Endodontic Pulp Canal File, Part Number: 830-9925. For use in root canal preparation. | A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error. | Terminated | ||
| Z-0916-2008 | Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740 | Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07. | Terminated | ||
| Z-0204-06 | Damon 3 Bracket Upper Right lateral .022 slot Part Number 491-4211 Lot Number 100514071 and 100512012 | Two part numbers of Damon 3 Brackets (491-4210 and 491-4211) were prematurely shipped domestically prior to receiving FDA 510K market clearance. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain