Sealant, Pit And Fissure, And Conditioner
Regulation 872.3765
1510(k)s in 12 months (131 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in EBC
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 11 | 0 |
| Pulpdent Corp. | 10 | 0 |
| Ultradent Products, Inc. | 7 | 1 |
| Voco GmbH | 5 | 0 |
| Confi-Dental Products Co. | 4 | 0 |
| 3M Company | 3 | 0 |
| Bisco, Inc. | 3 | 0 |
| Foremost Dental Mfg., Inc. | 3 | 0 |
| Harry J. Bosworth Co. | 3 | 0 |
| Johnson & Johnson Professionals, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2016 | Ultradent Products, Inc. UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus.
Product Usage:
The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for Terminated |
EBC | K993846 |
| Feb 29, 2016 | Ivoclar Vivadent, Inc. Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant Terminated |
EBC | K813015 |
| Nov 4, 2015 | Ivoclar A. G. Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortment (kit) 5 x 1.25 g, REF 558518AN. Dental sealant. -- ivoclar vivadent clinical --- Helioseal F Refill is provided in a s Terminated |
EBC | K932078 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.