The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Fascination Ceramic Bracket.
| Device ID | K935139 |
| 510k Number | K935139 |
| Device Name: | FASCINATION CERAMIC BRACKET |
| Classification | Bracket, Metal, Orthodontic |
| Applicant | DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | John J Roth, Jr. |
| Correspondent | John J Roth, Jr. DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | EJF |
| CFR Regulation Number | 872.5410 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-28 |
| Decision Date | 1994-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J011718742850 | K935139 | 000 |
| J011718742800 | K935139 | 000 |
| J011718741850 | K935139 | 000 |
| J011718702830 | K935139 | 000 |
| J011718702750 | K935139 | 000 |
| J011718702730 | K935139 | 000 |