The following data is part of a premarket notification filed by Shofu Dental Corporation with the FDA for Vintage Art Universal.
| Device ID | K191794 |
| 510k Number | K191794 |
| Device Name: | Vintage Art Universal |
| 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 | 2019-07-03 |
| Decision Date | 2019-10-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E235P16960 | K191794 | 000 |
| E235P07060 | K191794 | 000 |
| E235P07050 | K191794 | 000 |
| E235P07040 | K191794 | 000 |
| E235P07030 | K191794 | 000 |
| E235P07020 | K191794 | 000 |
| E235P07010 | K191794 | 000 |
| E235P07000 | K191794 | 000 |
| E235P06990 | K191794 | 000 |
| E235P06980 | K191794 | 000 |
| E235P06970 | K191794 | 000 |
| E235P06960 | K191794 | 000 |
| E235P06950 | K191794 | 000 |
| E235P06940 | K191794 | 000 |
| E235P06930 | K191794 | 000 |
| E235P06920 | K191794 | 000 |
| E235P07070 | K191794 | 000 |
| E235P07080 | K191794 | 000 |
| E235P07090 | K191794 | 000 |
| E235P16950 | K191794 | 000 |
| E235P07230 | K191794 | 000 |
| E235P07220 | K191794 | 000 |
| E235P07210 | K191794 | 000 |
| E235P07200 | K191794 | 000 |
| E235P07190 | K191794 | 000 |
| E235P07180 | K191794 | 000 |
| E235P07170 | K191794 | 000 |
| E235P07160 | K191794 | 000 |
| E235P07150 | K191794 | 000 |
| E235P07140 | K191794 | 000 |
| E235P07130 | K191794 | 000 |
| E235P07120 | K191794 | 000 |
| E235P07110 | K191794 | 000 |
| E235P07100 | K191794 | 000 |
| E235P06910 | K191794 | 000 |