Data / Medical devices / Pin, Retentive And Splinting, And Accessory Instruments / United States
FDA-registered makers of Pin, Retentive And Splinting, And Accessory Instruments in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Pin, Retentive And Splinting, And Accessory Instruments (product code EBL). 0 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Pin, Retentive And Splinting, And Accessory Instruments
- Product code
- EBL
- Country
- United States
Makers of Pin, Retentive And Splinting, And Accessory Instruments in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Accumedix, Inc. | Libertyville, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blue Sky Bio, LLC | Libertyville, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brasseler U.S.A. Dental, LLC | Savannah, GA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Coltene/Whaledent Inc. | Cuyahoga Falls, OH, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentistry Elevated | Wellsville, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hager Worldwide, Inc. | Hickory, NC, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lenjoy Medical Engineering, Inc. | Gardena, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mahe Medical Usa | Laramie, WY, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. 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.