UltraTemp Rez II— 510(k) K211237
Substantially EquivalentUltradent Products, Inc.
FDA 510(k) clearance K211237 for UltraTemp Rez II, Substantially Equivalent on 2021-07-13. Applicant: Ultradent Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Ultradent Products, Inc.
- Product code
- Code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Jordan, UT, US
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