AcceleDent Aura— 510(k) K153048

Substantially Equivalent

Orthoaccel Technologies, Inc.

FDA 510(k) clearance K153048 for AcceleDent Aura, Substantially Equivalent on 2016-07-08. Applicant: Orthoaccel Technologies, Inc..

Clearance details

Applicant: Orthoaccel Technologies, Inc.
Product code: Code OYH
Advisory panel: Dental
Date received: 2015-10-19
Decision date: 2016-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellaire, TX, US

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