Data / Medical devices / Needle, Dental / United States
FDA-registered makers of Needle, Dental in the United States: 15 establishments
15 establishments in the United States are registered with the FDA to make Needle, Dental (product code DZM). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Needle, Dental
- Product code
- DZM
- Country
- United States
Makers of Needle, Dental in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Dentsply LLC | York, PA, United States | Specification developer | 1 | April 28, 1992 | 0 | 0 | 0 | api.fda.gov |
| Exelint International, Co. | Redondo Beach, CA, United States | Manufacturer, Specification developer | 1 | April 11, 1986 | 0 | 0 | 0 | api.fda.gov |
| Tulsa Dental Products LLC | Johnson City, TN, United States | Manufacturer | 1 | April 27, 1999 | 0 | 0 | 0 | api.fda.gov |
| 3D Dental Desings And Development | Shaker Heights, OH, United States | Contract manufacturer | 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 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Deland, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Products Lab | Seattle, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kerr Corporation | Pomona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Practicon, Inc. | Greenville, NC, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulpdent Corporation | Watertown, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ready Set Import | Beverly Hills, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Belport Company, Inc DBA Gingi-Pak | Camarillo, CA, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xlent Global Inc | Las Vegas, NV, United States | 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.