The following data is part of a premarket notification filed by 3m Unitek with the FDA for Transbond Idb Pre-mix Chemical Care Adhesive.
| Device ID | K100536 |
| 510k Number | K100536 |
| Device Name: | TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | 3M UNITEK 2724 SOUTH PECK RD. Monrovia, CA 91016 |
| Contact | Niedre M Heckman |
| Correspondent | Niedre M Heckman 3M UNITEK 2724 SOUTH PECK RD. Monrovia, CA 91016 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-25 |
| Decision Date | 2010-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00652221151971 | K100536 | 000 |
| 00652221151964 | K100536 | 000 |
| 00652221151957 | K100536 | 000 |