UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio— 510(k) K232498
Substantially EquivalentUltradent Product, Inc.
FDA 510(k) clearance K232498 for UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio, Substantially Equivalent on 2023-08-18. Applicant: Ultradent Product, Inc.. Device class: 2.
Clearance details
- Applicant
- Ultradent Product, Inc.
- Product code
- Code EBC
- Device class
- Class 2
- Regulation
- 21 CFR 872.3765
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
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