The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Adhesive Precoated Brackets.
Device ID | K911271 |
510k Number | K911271 |
Device Name: | ADHESIVE PRECOATED BRACKETS |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
Contact | Marlyn Scheff |
Correspondent | Marlyn Scheff UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-22 |
Decision Date | 1991-05-29 |