The following data is part of a premarket notification filed by Sdi Limited with the FDA for Zipbond.
Device ID | K191656 |
510k Number | K191656 |
Device Name: | Zipbond |
Classification | Agent, Tooth Bonding, Resin |
Applicant | SDI Limited 3-15 Brunsdon Street Bayswater, AU 3153 |
Contact | Ray Cahill |
Correspondent | Ray Cahill SDI Limited 3-15 Brunsdon Street Bayswater, AU 3153 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-06-21 |
Decision Date | 2019-12-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ZIPBOND 72389922 0944406 Dead/Expired |
TESCOM CORPORATION 1971-04-21 |