The following data is part of a premarket notification filed by Dent Zar, Inc. with the FDA for Acorn Anterior/posterior Composite Restorative.
| Device ID | K960565 |
| 510k Number | K960565 |
| Device Name: | ACORN ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DENT ZAR, INC. 6362 HOLLYWOOD BLVD., #214 Los Angeles, CA 90028 |
| Contact | Eugene Zarotsky |
| Correspondent | Eugene Zarotsky DENT ZAR, INC. 6362 HOLLYWOOD BLVD., #214 Los Angeles, CA 90028 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-09 |
| Decision Date | 1996-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D83600331 | K960565 | 000 |
| D83600180 | K960565 | 000 |
| D83600170 | K960565 | 000 |
| D83600160 | K960565 | 000 |
| D83600150 | K960565 | 000 |
| D83600140 | K960565 | 000 |
| D83600130 | K960565 | 000 |
| D83600120 | K960565 | 000 |
| D83600110 | K960565 | 000 |
| D83600100 | K960565 | 000 |
| D83600090 | K960565 | 000 |
| D83600190 | K960565 | 000 |
| D83600221 | K960565 | 000 |
| D83600321 | K960565 | 000 |
| D83600311 | K960565 | 000 |
| D83600301 | K960565 | 000 |
| D83600291 | K960565 | 000 |
| D83600281 | K960565 | 000 |
| D83600271 | K960565 | 000 |
| D83600261 | K960565 | 000 |
| D83600251 | K960565 | 000 |
| D83600241 | K960565 | 000 |
| D83600231 | K960565 | 000 |
| D83600080 | K960565 | 000 |