Submission Details
| 510(k) Number | K232498 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 17, 2023 |
| Decision Date | August 18, 2023 |
| Days to Decision | 1 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
Aug 2023
Decision
1d
Days
Class 2
Risk
About This 510(k) Submission
K232498 is an FDA 510(k) clearance for the UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio, a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC), submitted by Ultradent Product, Inc. (South Jordan, US). The FDA issued a Cleared decision on August 18, 2023, 1 days after receiving the submission on August 17, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3765.
Device Classification
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.3765 |
Manufacturer
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