The following data is part of a premarket notification filed by Pulpdent Corp. Of America with the FDA for Polycarb Water Set.
| Device ID | K853447 |
| 510k Number | K853447 |
| Device Name: | POLYCARB WATER SET |
| Classification | Cement, Dental |
| Applicant | PULPDENT CORP. OF AMERICA 75 BOYLSTON ST. P.O. BOX 689 Brookline, MA 02147 |
| Contact | Kenneth J Berk |
| Correspondent | Kenneth J Berk PULPDENT CORP. OF AMERICA 75 BOYLSTON ST. P.O. BOX 689 Brookline, MA 02147 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-16 |
| Decision Date | 1985-10-16 |