The following data is part of a premarket notification filed by 3m Espe Dental Products with the FDA for Sea2 Self Etch Adhesive.
| Device ID | K070956 |
| 510k Number | K070956 |
| Device Name: | SEA2 SELF ETCH ADHESIVE |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | 3M ESPE DENTAL PRODUCTS 3M CENTER; BLDG 260-2A-11 St. Paul, MN 55144 -1000 |
| Contact | Karen O'malley |
| Correspondent | Karen O'malley 3M ESPE DENTAL PRODUCTS 3M CENTER; BLDG 260-2A-11 St. Paul, MN 55144 -1000 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-05 |
| Decision Date | 2007-05-22 |
| Summary: | summary |