The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Vintage Mp Press Over.
| Device ID | K122614 |
| 510k Number | K122614 |
| Device Name: | VINTAGE MP PRESS OVER |
| Classification | Powder, Porcelain |
| Applicant | SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos, CA 92078 |
| Contact | David P Morais |
| Correspondent | David P Morais SHOFU DENTAL CORPORATION 1225 STONE DRIVE San Marcos, CA 92078 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-27 |
| Decision Date | 2013-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E23596620 | K122614 | 000 |
| E23596430 | K122614 | 000 |
| E23596440 | K122614 | 000 |
| E23596450 | K122614 | 000 |
| E23596460 | K122614 | 000 |
| E23596470 | K122614 | 000 |
| E23596490 | K122614 | 000 |
| E23596500 | K122614 | 000 |
| E23596510 | K122614 | 000 |
| E23596530 | K122614 | 000 |
| E23596540 | K122614 | 000 |
| E23596570 | K122614 | 000 |
| E23596590 | K122614 | 000 |
| E23596410 | K122614 | 000 |