AcceleDent Aura— 510(k) K153048
Substantially EquivalentOrthoaccel Technologies, Inc.
FDA 510(k) clearance K153048 for AcceleDent Aura, Substantially Equivalent on 2016-07-08. Applicant: Orthoaccel Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Orthoaccel Technologies, Inc.
- Product code
- Code OYH
- Device class
- Class 2
- Regulation
- 21 CFR 872.5470
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bellaire, TX, US
Recent devices under product code OYH
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