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FDA 510(k)

AcceleDent Optima

K-Number: K170093 · 2017-05-26

ApplicantOrthoaccel Technology, Inc.
Decision Date2017-05-26
Product CodeOYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AcceleDent Optima is the device name listed in this FDA 510(k) record. The listed applicant is Orthoaccel Technology, Inc.. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K170093. 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 Optima?

AcceleDent Optima is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Orthoaccel Technology, Inc.. The 510(k) number is K170093.

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

AcceleDent Optima received FDA 510(k) clearance on 2017-05-26, under 510(k) number K170093.

Who is the listed applicant for AcceleDent Optima?

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

What is the FDA product code for AcceleDent Optima?

The FDA product code for AcceleDent Optima 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, LLCK153048AcceleDent AuraOrthoaccel Technologies, 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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