Not currently registered with FDA under this name
Premier Dental Company Products
Plymouth Meeting, PA, United States. Named as applicant on 3 dental 510(k) clearances between 2015 and 2019. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 32015–2019
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2007–2026
510(k) clearances
Clearances on which FDA names Premier Dental Company Products as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 27 Feb 2019 | K180682 | AeroPro Cordless Prophy System | EKX Ac-Powered Direct Drive Handpiece |
| 18 Oct 2016 | K161580 | Premier Sealant | EBC Pit and Fissure Sealant and Conditioner |
| 22 Jul 2015 | K150601 | Zeramic Adhesive Resin Cement | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: Premier Dental Products Company (3), B.J.M. Laboratories Ltd (2).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.