The following data is part of a premarket notification filed by Ormco Corp. with the FDA for Sequence Light Cure Adhesive.
Device ID | K914727 |
510k Number | K914727 |
Device Name: | SEQUENCE LIGHT CURE ADHESIVE |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
Contact | Frances Zee |
Correspondent | Frances Zee ORMCO CORP. 1332 SOUTH LONE HILL AVE. Glendora, CA 91740 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-21 |
Decision Date | 1992-01-17 |