The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Vintage Prime Press.
| Device ID | K212939 |
| 510k Number | K212939 |
| Device Name: | Vintage Prime Press |
| Classification | Powder, Porcelain |
| Applicant | Shofu Dental Corporation 1225 Stone Drive San Marcos, CA 92078 |
| Contact | Mauro Malzyner |
| Correspondent | Mauro Malzyner 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 | 2021-09-15 |
| Decision Date | 2022-03-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E235P08111 | K212939 | 000 |
| E235P08261 | K212939 | 000 |
| E235P08271 | K212939 | 000 |
| E235P08281 | K212939 | 000 |
| E235P08291 | K212939 | 000 |
| E235P08301 | K212939 | 000 |
| E235P08311 | K212939 | 000 |
| E235P08321 | K212939 | 000 |
| E235P08331 | K212939 | 000 |
| E235P08341 | K212939 | 000 |
| E235P08251 | K212939 | 000 |
| E235P08241 | K212939 | 000 |
| E235P08121 | K212939 | 000 |
| E235P08131 | K212939 | 000 |
| E235P08141 | K212939 | 000 |
| E235P08151 | K212939 | 000 |
| E235P08161 | K212939 | 000 |
| E235P08201 | K212939 | 000 |
| E235P08211 | K212939 | 000 |
| E235P08221 | K212939 | 000 |
| E235P08231 | K212939 | 000 |
| E235P08351 | K212939 | 000 |
| E235P08361 | K212939 | 000 |
| E235P08501 | K212939 | 000 |
| E235P08511 | K212939 | 000 |
| E235P08521 | K212939 | 000 |
| E235P08531 | K212939 | 000 |
| E235P08541 | K212939 | 000 |
| E235P08551 | K212939 | 000 |
| E235P08561 | K212939 | 000 |
| E235P08571 | K212939 | 000 |
| E235P08601 | K212939 | 000 |
| E235P08491 | K212939 | 000 |
| E235P08481 | K212939 | 000 |
| E235P08371 | K212939 | 000 |
| E235P08401 | K212939 | 000 |
| E235P08411 | K212939 | 000 |
| E235P08421 | K212939 | 000 |
| E235P08431 | K212939 | 000 |
| E235P08441 | K212939 | 000 |
| E235P08451 | K212939 | 000 |
| E235P08461 | K212939 | 000 |
| E235P08471 | K212939 | 000 |
| E235P08701 | K212939 | 000 |