The following data is part of a premarket notification filed by Ethicare with the FDA for Plaq-ataq-i.
| Device ID | K980995 |
| 510k Number | K980995 |
| Device Name: | PLAQ-ATAQ-I |
| Classification | Toothbrush, Manual |
| Applicant | ETHICARE P.O. BOX 5027 Ft. Lauderdale, FL 33310 |
| Contact | Seymour Troy |
| Correspondent | Seymour Troy ETHICARE P.O. BOX 5027 Ft. Lauderdale, FL 33310 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-27 |
| Decision Date | 1998-08-20 |