The following data is part of a premarket notification filed by 3m Unitek Corporation with the FDA for Apc Flash-free Adhesive.
| Device ID | K113197 |
| 510k Number | K113197 |
| Device Name: | APC FLASH-FREE ADHESIVE |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | 3M UNITEK CORPORATION 2724 SOUTH PECK RD. Monrovia, CA 91016 |
| Contact | Robert Wang |
| Correspondent | Robert Wang 3M UNITEK CORPORATION 2724 SOUTH PECK RD. Monrovia, CA 91016 |
| Product Code | DYH |
| Subsequent Product Code | EJF |
| Subsequent Product Code | NJM |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-02-02 |
| Summary: | summary |