The following data is part of a premarket notification filed by Teen Care, Inc. with the FDA for Teen Clean, Retainer Cleaner.
| Device ID | K860737 |
| 510k Number | K860737 |
| Device Name: | TEEN CLEAN, RETAINER CLEANER |
| Classification | Cleanser, Denture, Over The Counter |
| Applicant | TEEN CARE, INC. STUART LEE FRIEDEL 850 THIRD AVENUE New York, NY 10022 |
| Contact | & Gilbert |
| Correspondent | & Gilbert TEEN CARE, INC. STUART LEE FRIEDEL 850 THIRD AVENUE New York, NY 10022 |
| Product Code | EFT |
| CFR Regulation Number | 872.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-27 |
| Decision Date | 1986-03-26 |