The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Advanced Glass Ionomer (k-130) Restorative.
| Device ID | K101493 |
| 510k Number | K101493 |
| Device Name: | ADVANCED GLASS IONOMER (K-130) RESTORATIVE |
| Classification | Cement, Dental |
| Applicant | DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. SUSQUEHANNA COMMERCE CTR., 221 W. PHILADELPHIA ST., SUITE 60 York, PA 17404 |
| Product Code | EMA |
| Subsequent Product Code | EBC |
| Subsequent Product Code | EBF |
| Subsequent Product Code | EJK |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-01 |
| Decision Date | 2010-08-19 |
| Summary: | summary |