The following data is part of a premarket notification filed by U.s. Dentek Corp. with the FDA for Super Pik Massaging Pick For Oral Hygiene.
| Device ID | K881046 |
| 510k Number | K881046 |
| Device Name: | SUPER PIK MASSAGING PICK FOR ORAL HYGIENE |
| Classification | Pick, Massaging |
| Applicant | U.S. DENTEK CORP. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BOULEVARD Los Angeles, CA 90064 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller U.S. DENTEK CORP. WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BOULEVARD Los Angeles, CA 90064 |
| Product Code | JET |
| CFR Regulation Number | 872.6650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-11 |
| Decision Date | 1988-05-13 |