The following data is part of a premarket notification filed by Dentek Corp. with the FDA for Massaging Pick For Oral Hygiene.
Device ID | K885189 |
510k Number | K885189 |
Device Name: | MASSAGING PICK FOR ORAL HYGIENE |
Classification | Pick, Massaging |
Applicant | DENTEK CORP. 32 LEVERONI COURT SUITE 101 Novato, CA 94949 |
Contact | John M Jansheski |
Correspondent | John M Jansheski DENTEK CORP. 32 LEVERONI COURT SUITE 101 Novato, CA 94949 |
Product Code | JET |
CFR Regulation Number | 872.6650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-12-16 |
Decision Date | 1989-03-17 |