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FDA 510(k)

AcceleDent Aura

K-Number: K153048 · 2016-07-08

ApplicantOrthoaccel Technologies, Inc.
Decision Date2016-07-08
Product CodeOYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AcceleDent Aura is the device name listed in this FDA 510(k) record. The listed applicant is Orthoaccel Technologies, Inc.. It received FDA 510(k) clearance on 2016-07-08 under 510(k) number K153048. The device is classified under product code OYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcceleDent Aura?

AcceleDent Aura is a medical device that received FDA 510(k) clearance on 2016-07-08. The listed applicant is Orthoaccel Technologies, Inc.. The 510(k) number is K153048.

When did AcceleDent Aura receive FDA 510(k) clearance?

AcceleDent Aura received FDA 510(k) clearance on 2016-07-08, under 510(k) number K153048.

Who is the listed applicant for AcceleDent Aura?

The FDA 510(k) record lists Orthoaccel Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AcceleDent Aura?

The FDA product code for AcceleDent Aura is OYH.

Related Devices (Code: OYH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183018VPro5Propel Orthodontics, LLCK170093AcceleDent OptimaOrthoaccel Technology, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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