The following data is part of a premarket notification filed by Dent Zar, Inc. with the FDA for Skyrock And Light Superbond.
Device ID | K894639 |
510k Number | K894639 |
Device Name: | SKYROCK AND LIGHT SUPERBOND |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | DENT ZAR, INC. 8721 SANTA MONICA BLVD. BOX 650 Los Angeles, CA 90069 |
Contact | David Zarotsky |
Correspondent | David Zarotsky DENT ZAR, INC. 8721 SANTA MONICA BLVD. BOX 650 Los Angeles, CA 90069 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-07-24 |
Decision Date | 1989-10-20 |