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 |
|---|---|---|
| J011700501010 | K935139 | 000 |
| J011700514010 | K935139 | 000 |
| J011700515010 | K935139 | 000 |
| J011700516010 | K935139 | 000 |
| J011700517010 | K935139 | 000 |
| J011700518010 | K935139 | 000 |
| J011700519010 | K935139 | 000 |
| J011700520010 | K935139 | 000 |
| J011700521010 | K935139 | 000 |
| J011700522010 | K935139 | 000 |
| J011700513010 | K935139 | 000 |
| J011700512010 | K935139 | 000 |
| J011700511010 | K935139 | 000 |
| J011700502010 | K935139 | 000 |
| J011700503010 | K935139 | 000 |
| J011700504010 | K935139 | 000 |
| J011700505010 | K935139 | 000 |
| J011700506010 | K935139 | 000 |
| J011700507010 | K935139 | 000 |
| J011700508010 | K935139 | 000 |
| J011700509010 | K935139 | 000 |
| J011700510010 | K935139 | 000 |
| J011700523010 | K935139 | 000 |
| J011700524010 | K935139 | 000 |
| J011700537010 | K935139 | 000 |
| J011700538010 | K935139 | 000 |
| J011700539010 | K935139 | 000 |
| J011700540010 | K935139 | 000 |
| J011718702730 | K935139 | 000 |
| J011718702750 | K935139 | 000 |
| J011718702830 | K935139 | 000 |
| J011718741850 | K935139 | 000 |
| J011718742800 | K935139 | 000 |
| J011700536010 | K935139 | 000 |
| J011700535010 | K935139 | 000 |
| J011700534010 | K935139 | 000 |
| J011700525010 | K935139 | 000 |
| J011700526010 | K935139 | 000 |
| J011700527010 | K935139 | 000 |
| J011700528010 | K935139 | 000 |
| J011700529010 | K935139 | 000 |
| J011700530010 | K935139 | 000 |
| J011700531010 | K935139 | 000 |
| J011700532010 | K935139 | 000 |
| J011700533010 | K935139 | 000 |
| J011718742850 | K935139 | 000 |