The following data is part of a premarket notification filed by Lincoln Park Dental Laboratory with the FDA for Clean Dent.
Device ID | K890668 |
510k Number | K890668 |
Device Name: | CLEAN DENT |
Classification | Cleanser, Denture, Over The Counter |
Applicant | LINCOLN PARK DENTAL LABORATORY 1500 LOUCKS RD. York, PA 17404 |
Contact | Albert G Munchel |
Correspondent | Albert G Munchel LINCOLN PARK DENTAL LABORATORY 1500 LOUCKS RD. York, PA 17404 |
Product Code | EFT |
CFR Regulation Number | 872.3520 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-09 |
Decision Date | 1989-04-17 |