The following data is part of a premarket notification filed by Cendres & Metaux Sa with the FDA for Pekkton Ivory.
| Device ID | K123638 |
| 510k Number | K123638 |
| Device Name: | PEKKTON IVORY |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | CENDRES & METAUX SA RUE DE BOUJEAN 122 Biel/bienne, CH 2501 |
| Contact | T. Bongni |
| Correspondent | T. Bongni CENDRES & METAUX SA RUE DE BOUJEAN 122 Biel/bienne, CH 2501 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-26 |
| Decision Date | 2013-02-21 |
| Summary: | summary |