The following data is part of a premarket notification filed by Caulk Co., Div. Dentsply with the FDA for Prisma-fil Compules.
| Device ID | K812277 |
| 510k Number | K812277 |
| Device Name: | PRISMA-FIL COMPULES |
| Classification | Syringe, Restorative And Impression Material |
| Applicant | CAULK CO., DIV. DENTSPLY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EID |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-13 |
| Decision Date | 1981-09-08 |