Data / Medical devices / United States / H & H Co.
H & H Co.: FDA-registered device maker in Hayden, ID, United States, 2 510(k) clearances
H & H Co. is registered with the FDA (registration 2085199) in Hayden, ID, United States. It lists 52 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2085199
- FEI number
- 1000160732
- Address
- 11888 N Tracey Rd, Hayden, ID, United States, 83835
- Owner or operator
- W.H. Holden Inc. DBA H & H Company (9010035)
- Roles
- Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 8, 2003
- Registered through
- 2026
- Brand names listed
- BONE CHISELS, BONE CRUSHER, BONE PARTICLE COLLECTOR, BURS, CARRIER, ALMALGAM, CLAMP, CONDENSERS, CURETTE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Accessories, Retractor, Dental | EIF | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bone Mill | LYS | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bone Particle Collector | MXP | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Carrier, Amalgam, Operative | EKI | 1 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Clamp, Wire, Orthodontic | ECN | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Condenser, Amalgam And Foil, Operative | EKG | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Operative | EKE | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Curette, Periodontic | EMS | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Drill, Bone, Powered | DZI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | 2 | Repackager or relabeler | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Explorer, Operative | EKB | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| File, Bone, Surgical | EMI | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| File, Periodontic | EMR | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Forceps, Tooth Extractor, Surgical | EMG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gag, Mouth | KBN | 1 | Contract manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hemostat, Surgical | EMD | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Hoe, Periodontic | EMQ | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle, Gastroenterologic | FHQ | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Irrigator, Sinus | KAR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Periodontic | EMO | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Light, Fiber Optic, Dental | EAY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet | HXL | 1 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Aspiration And Injection, Reusable | GDM | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Manufacturer, Remanufacturer | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Probe, Periodontic | EIX | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Punch, Biopsy, Surgical | EME | 1 | Repackager or relabeler | accessdata.fda.gov |
| Remover, Crown | EIS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Periodontic | EMN | 1 | Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Contract manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Speculum, Ent | EPY | 1 | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Remanufacturer, Repackager or relabeler | accessdata.fda.gov |
| Trephine, Sinus | KBF | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 26, 2022 | K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | ERL | Substantially Equivalent | W&H Dentalwerk Buermoss GmbH | accessdata.fda.gov |
| August 22, 2019 | K181888 | Osstell Beacon | EKX | Substantially Equivalent | Osstell AB | accessdata.fda.gov |
Compare with other makers
- All makers of Forceps, Dressing, Dental
- All makers of Holder, Needle, Gastroenterologic
- All makers of Drill, Dental, Intraoral
- All makers of Forceps
- All makers of Tray, Surgical, Instrument
- All makers of Scaler, Periodontic
Updated May 26, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.