The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Dental Alginate Impression Material W/anti. Addi..
| Device ID | K883842 |
| 510k Number | K883842 |
| Device Name: | DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. |
| Classification | Material, Impression |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | O Semmelman |
| Correspondent | O Semmelman DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-12 |
| Decision Date | 1989-03-17 |