Ultrafast, Ultrafast Plus, Ultrafast Lite— 510(k) K201387
Substantially EquivalentDentlight, Inc.
FDA 510(k) clearance K201387 for Ultrafast, Ultrafast Plus, Ultrafast Lite, Substantially Equivalent on 2021-02-26. Applicant: Dentlight, Inc.. Device class: 2.
Clearance details
- Applicant
- Dentlight, Inc.
- Product code
- Code NVK
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
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