The following data is part of a premarket notification filed by Dent Zar, Inc. with the FDA for Light Super Bond-1 Light Cured Orthodontic Adhesive For Metal, Plastic And Ceramic Brackets.
Device ID | K960594 |
510k Number | K960594 |
Device Name: | LIGHT SUPER BOND-1 LIGHT CURED ORTHODONTIC ADHESIVE FOR METAL, PLASTIC AND CERAMIC BRACKETS |
Classification | Material, Tooth Shade, Resin |
Applicant | DENT ZAR, INC. 19643 TRULL BROOK DR. Tarzana, CA 91356 |
Contact | Eugene Zarotsky |
Correspondent | Eugene Zarotsky DENT ZAR, INC. 19643 TRULL BROOK DR. Tarzana, CA 91356 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-12 |
Decision Date | 1996-04-26 |