510(k) K993846 ยท EBC Sealant, Pit And Fissure, And Conditioner
ULTRASEAL XT PLUS
| Applicant | Ultradent Products, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Feb 16, 2000 |
| Received | Nov 12, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993846
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.