Ortho Organizers Inc
Savannah, GA, US
ORTHO ORGANIZERS, INC. appears in FDA device records in Savannah, GA. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Ortho Organizers Inc between 1993 and 2025. The busiest year on record is 1993, with 3. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 3 |
| 2006 | 1 |
| 2011 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252760 | Carriere® Motion Pro® Clear Bite Corrector | DYW | Substantially Equivalent | |
| K173440 | Carriere SLX 3D Clear | NJM | Substantially Equivalent | |
| K160720 | Carriere Motion Clear Class II | DYW | Substantially Equivalent | |
| K110335 | CERAMIC BRACKETS | NJM | Substantially Equivalent | |
| K061266 | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR | OAT | Substantially Equivalent | |
| K923218 | NITANIUM PALATAL EXPANDER | EJF | Substantially Equivalent | |
| K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS | DYO | Substantially Equivalent | |
| K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | EJF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2081322 | 2081322 | ORTHO ORGANIZERS, INC. | 800 King George Blvd, Suite 100, Savannah, GA 31419 US | 2026 | and 30 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EJRAgent, Polishing, Abrasive, Oral Cavity
- ECQAligner, Bracket, Orthodontic
- NXCAligner, Sequential
- KXRApplicator, Resin
- ECIBand, Elastic, Orthodontic
- DYOBand, Material, Orthodontic
- ECMBand, Preformed, Orthodontic
- NJMBracket, Ceramic, Orthodontic
- EJFBracket, Metal, Orthodontic
- DYWBracket, Plastic, Orthodontic
- EJLBur, Dental
- ECNClamp, Wire, Orthodontic
- EHPClasp, Preformed
- EFTCleanser, Denture, Over The Counter
- EHJDisk, Abrasive
- IWZFilm, Radiographic
- JESFloss, Dental
- EILGauge, Depth, Instrument, Dental
- EJBHandle, Instrument, Dental
- DZBHeadgear, Extraoral, Orthodontic
- OATImplant, Endosseous, Orthodontic
- ECPInstrument, Ligature Tucking, Orthodontic
- DZNInstruments, Dental Hand
- DYTMaintainer, Space Preformed, Orthodontic
- ELWMaterial, Impression
- EAXMirror, Mouth
- MQCMouthguard, Prescription
- JEXPlier, Orthodontic
- KMYPositioner, Tooth, Preformed
- ECSPusher, Band, Orthodontic
- DYJRetainer, Screw Expansion, Orthodontic
- EIGRetractor, All Types
- EMNScaler, Periodontic
- ECRSetter, Band, Orthodontic
- ECOSpring, Orthodontic
- EHMStrip, Polishing Agent
- FTYTape, Measuring, Rulers And Calipers
- EFWToothbrush, Manual
- EHYTray, Impression, Preformed
- DZDTube, Orthodontic
- EGDWax, Dental, Intraoral
- DZCWire, Orthodontic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2478-2020 | Maestro Orthodontic Bracket REF711-298Q QTY. 20 Rx Only (01)00190707017064 (10)889437 (422)484 Maestro Orthodontic Bracket REF711-299MCQ QTY. 20 Rx Only (01)00190707017071(10)889437 (422)484 | Orthodontic Bracket is mislabeled | Class II | Terminated | |
| Z-2477-2020 | Maestro Orthodontic Bracket REF711-206-10 QTY. 10 Rx Only (01)00190707016517 (10)112233 (422)484 | Orthodontic Bracket is mislabeled | Class II | Terminated | |
| Z-1246-2011 | ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-327 (NF DB UR 6 Convertible .018-14T 14DO HK-Each); ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-328, NF DB UL 6 Convertible .018-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-418, NF DB UL/LR 6&7 Mini Single .022 0T 0O; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-427, NF DB UR 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Label ID Reference Number 351-428, NF DB UL 6 Convertible .022-14T 14DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-459, NF DB LR 6 Convertible .022-25T 4DO HK-Each; ClassOne Orthodontics Buccal SS Tubes Label ID Reference Number 351-460, NF DB LL 6 Convertible .022-25T 4DO HK-Each. | Products were mis-labeled as nickel free. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain