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 |