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 |