The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for 4 All (dw286a).
| Device ID | K020253 |
| 510k Number | K020253 |
| Device Name: | 4 ALL (DW286A) |
| Classification | Alloy, Metal, Base |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Anderjeet Gulati |
| Correspondent | Anderjeet Gulati IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-24 |
| Decision Date | 2002-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970553800215 | K020253 | 000 |
| 06970553800055 | K020253 | 000 |
| 06970553800062 | K020253 | 000 |
| 06970553800079 | K020253 | 000 |
| 06970553800086 | K020253 | 000 |
| 06970553800109 | K020253 | 000 |
| 06970553800116 | K020253 | 000 |
| 06970553800123 | K020253 | 000 |
| 06970553800130 | K020253 | 000 |
| 06970553800147 | K020253 | 000 |
| 06970553800154 | K020253 | 000 |
| 06970553800161 | K020253 | 000 |
| 06970553800178 | K020253 | 000 |
| 06970553800185 | K020253 | 000 |
| 06970553800192 | K020253 | 000 |
| 06970553800208 | K020253 | 000 |
| 06970553800003 | K020253 | 000 |