HU-Friedy Mfg. Co. LLC
Northbrook, IL, US
HU-FRIEDY MFG. CO. LLC appears in FDA device records in Northbrook, IL. FDA records list 9 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 8 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 9 510(k) clearances for HU-Friedy Mfg. Co. LLC between 1984 and 2012. The busiest year on record is 1984, with 1. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1991 | 1 |
| 1995 | 1 |
| 2001 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K120659 | HU-FRIEDY DENTAL CARTRIDGE SYRINGE | EJI | Substantially Equivalent | |
| K100401 | SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM | ELC | Substantially Equivalent | |
| K073369 | EI DOWNPAK BARRIER SLEEVES | EKM | Substantially Equivalent | |
| K070975 | SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES | ELC | Substantially Equivalent | |
| K053178 | SYMMETRY S-SERIES PIEZOELECTRIC SCALING TIPS | ELC | Substantially Equivalent | |
| K012060 | MODIFICATION TO:HU-FRIEDY BRAND SATIN SWIVEL ULTRASONIC INSERT | ELC | Substantially Equivalent | |
| K953919 | DENTAL ULTRASONIC SCALER INSERTS | ELC | Substantially Equivalent | |
| K912473 | ACCU-PLACER TM KIT | EKJ | Substantially Equivalent | |
| K844002 | HU-FRIEDY IMS CASSETTE SYSTEM | FSM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009968482 | 3009968482 | HU-FRIEDY MFG CO., LLC | 1666 E Touhy Ave, Des Plaines, IL 60018 US | 2026 | and 66 more, listed in full below |
| 1416605 | 1416605 | HU-FRIEDY MFG. CO. LLC | 2501 Sanders Rd, Northbrook, IL 60062 US | 2026 | and 47 more, listed in full below |
| 3005049358 | 3005049358 | HU-FRIEDY MFG. CO. LLC | No. 29, LANE 1365, PUDONG, SHANGHAI 201319 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EJRAgent, Polishing, Abrasive, Oral Cavity
- EHOBar, Preformed
- EJLBur, Dental
- EKJBurnisher, Operative
- EKICarrier, Amalgam, Operative
- EKHCarver, Dental Amalgam, Operative
- EMLChisel, Bone, Surgical
- EEFClamp, Rubber Dam
- FLGCleaner, Ultrasonic, Medical Instrument
- EKGCondenser, Amalgam And Foil, Operative
- ELZCrown, Preformed
- EHKCup, Prophylaxis
- EMSCurette, Periodontic
- EMKCurette, Surgical, Dental
- EMJElevator, Surgical, Dental
- EHZEvacuator, Oral Cavity
- EKCExcavator, Dental, Operative
- EKBExplorer, Operative
- EMIFile, Bone, Surgical
- EKAFile, Margin Finishing, Operative
- EMRFile, Periodontic
- EFKForceps, Articulation Paper
- EFLForceps, Dressing, Dental
- EMHForceps, Rongeur, Surgical
- EJGForceps, Rubber Dam Clamp
- EMGForceps, Tooth Extractor, Surgical
- EJEFrame, Rubber Dam
- EILGauge, Depth, Instrument, Dental
- EKMGutta-Percha
- EJBHandle, Instrument, Dental
- EMDHemostat, Surgical
- EMQHoe, Periodontic
- FHQHolder, Needle, Gastroenterologic
- FRCIndicator, Biological Sterilization Process
- EKDInstrument, Cutting, Operative
- EIYInstrument, Filling, Plastic, Dental
- ECPInstrument, Ligature Tucking, Orthodontic
- EJZKnife, Margin Finishing, Operative
- EMOKnife, Periodontic
- EMFKnife, Surgical
- EMPMarker, Periodontic
- EAXMirror, Mouth
- EJYPliers, Operative
- EKRPlugger, Root Canal, Endodontic
- EIXProbe, Periodontic
- ECSPusher, Band, Orthodontic
- EISRemover, Crown
- EIGRetractor, All Types
- EMNScaler, Periodontic
- ELCScaler, Ultrasonic
- EIRScissors, Collar And Crown
- EGNScissors, Surgical Tissue, Dental
- GAFSpatula, Surgical, General & Plastic Surgery
- EKKSpreader, Pulp Canal Filling Material, Endodontic
- GALSuture, Absorbable, Natural
- EJISyringe, Cartridge
- EIBSyringe, Irrigating (Dental)
- FSMTray, Surgical, Instrument
- DZCWire, Orthodontic
- FRGWrap, Sterilization
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0529-05 | Dental Explorer Single End #7, Mfr. Part Code/Product Code 100-7409. Distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-7409 Explorer - Single End #7 SE. +H65810074090C. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers. | Terminated | ||
| Z-0528-05 | Dental Explorer D/E #5, Mfr. Part Code/Product Code 100-8008, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-8008 Explorer-Double End #5. +H658100800808. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers. | Terminated | ||
| Z-0527-05 | Dental Explorer #23 S/E, Mfr. Part Code/Product Code 100-3620, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. The product is labeled in part, HENRY SCHEIN 100-3620 Explorer-Single End #23 SE. +H658100362003. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers. | Terminated | ||
| Z-0526-05 | Dental Explorer #2 D/E, Mfr. Part Code/Product Code 101-0913, distributed under the Henry Schein label. Classification Name: 21CFR 872.4565; 510(k) exempt, Class I device, Device Listing # B057701. Product is labeled in part, HENRY SCHEIN 101-0913 Explorer #2 D/E. +H658101091306. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. --- This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification setter of the dental explorers. | Terminated | ||
| Z-0834-04 | HENRY SCHEIN(R) 100-8008 Explorer-Double End #5. Barcode *+H658100800808*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701. | Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture. | Terminated | ||
| Z-0833-04 | HENRY SCHEIN(R) 100-3620 Explorer-Single End #23 SE. Barcode *+H658100362003*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701. | Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture. | Terminated | ||
| Z-0832-04 | HENRY SCHEIN(R) 101-0913 Explorer #2 D/E. Barcode *+H658101091306*. Made in China. For professional use only. Instruments must be cleaned and sterilized prior to use. Distributed by: HENRY SCHEIN, INC. 135 Duryea Road, Melville, NY 11747 USA. This product is a dental explorer made of stainless steel packaged individually within a sleeve and containing a cardboard insert (labeling). 510 (k) exempt, Class I device, Device Listing # B057701. | Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture. | Terminated | ||
| Z-0802-03 | Non-Sterile Suture Needles, Reverse Cutting, 1/2 Circle, Stainless Steel; 12 suture needles per glass vial; partcode: SN4; Hu-Friedy Mfg. Co., Inc., 3232 N. Rockwell St., Chicago, IL 60618 | The suture needles were mislabeled with the wrong size. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain