SURESMILE SYSTEM— 510(k) K002620
Substantially EquivalentOrametrix, Inc.
FDA 510(k) clearance K002620 for SURESMILE SYSTEM, Substantially Equivalent on 2000-11-16. Applicant: Orametrix, Inc.. Device class: 1.
Clearance details
- Applicant
- Orametrix, Inc.
- Product code
- Code EIA
- Device class
- Class 1
- Regulation
- 21 CFR 872.6640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code EIA
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