The following data is part of a premarket notification filed by 3m Espe Dental Products with the FDA for Gilb-2, Glass Ionomer Protective Coating.
| Device ID | K073395 |
| 510k Number | K073395 |
| Device Name: | GILB-2, GLASS IONOMER PROTECTIVE COATING |
| Classification | Cement, Dental |
| 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 | EMA |
| Subsequent Product Code | EBC |
| Subsequent Product Code | EJK |
| Subsequent Product Code | LBH |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-12-03 |
| Decision Date | 2008-01-17 |
| Summary: | summary |