Data / Medical devices / Dental Barriers And Sleeves / United States
FDA-registered makers of Dental Barriers And Sleeves in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Dental Barriers And Sleeves (product code PEM). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Dental Barriers And Sleeves
- Product code
- PEM
- Country
- United States
Makers of Dental Barriers And Sleeves in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ready Set Import | Beverly Hills, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 3 | June 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| Air Techniques, Inc. | Melville, NY, United States | Manufacturer, Specification developer | 1 | July 26, 2019 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | Milford, DE, United States | Specification developer | 1 | June 7, 2016 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Manufacturer, Specification developer | 1 | June 7, 2016 | 0 | 0 | 0 | api.fda.gov |
| Dukal LLC | Ronkonkoma, NY, United States | Complaint file establishment, Specification developer | 1 | June 14, 2019 | 0 | 0 | 0 | api.fda.gov |
| Mouthwatch, Inc. | Metuchen, NJ, United States | Specification developer | 1 | August 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Nucare LLC | Montclair, CA, United States | Specification developer | 1 | September 10, 2019 | 0 | 0 | 0 | api.fda.gov |
| Tidi Products, LLC | Neenah, WI, United States | Contract manufacturer, Manufacturer | 1 | February 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| Maco Bag Corp. | Newark, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tulsa Dental Products LLC | Johnson City, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.