The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Enamel Microabrasion Compound.
| Device ID | K891536 |
| 510k Number | K891536 |
| Device Name: | ENAMEL MICROABRASION COMPOUND |
| Classification | Agent, Polishing, Abrasive, Oral Cavity |
| Applicant | PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. P.O. BOX 111 Norristown, PA 19401 |
| Contact | William J Frezel |
| Correspondent | William J Frezel PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. P.O. BOX 111 Norristown, PA 19401 |
| Product Code | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-06-09 |