Not currently registered with FDA under this name
Roydent Dental Products, Inc.
Rochester Hills, MI, United States. Named as applicant on 3 dental 510(k) clearances between 1996 and 1999. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 31996–1999
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Roydent Dental Products, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 4 Feb 1999 | K984037 | CORE-IDE | EBD Resin Filling Material Coating |
| 13 Nov 1998 | K983357 | MUCOPREN SOFT RELINING SYSTEM | EBI Rebasing Repairing Relining Denture Resin |
| 24 Jun 1996 | K954281 | PANASIL IMPRESSION MATERIAL | ELW Impression Material |
Some of these clearances are listed with FDA today by another company: Kettenbach GmbH & Co. KG (1).
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.