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FDA 510(k)

ACCELEDENT

K-Number: K110661 · 2011-11-17

ApplicantOrthoaccel Technologies, Inc.
Decision Date2011-11-17
Product CodeOYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACCELEDENT 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 2011-11-17 under 510(k) number K110661. 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?

ACCELEDENT is a medical device that received FDA 510(k) clearance on 2011-11-17. The listed applicant is Orthoaccel Technologies, Inc.. The 510(k) number is K110661.

When did ACCELEDENT receive FDA 510(k) clearance?

ACCELEDENT received FDA 510(k) clearance on 2011-11-17, under 510(k) number K110661.

Who is the listed applicant for ACCELEDENT?

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?

The FDA product code for ACCELEDENT is OYH.

Related Clinical Trials

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.

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Other records listing Orthoaccel Technologies, Inc. as applicant

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.

K153048AcceleDent AuraK130643ACCELEDENT AURA

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.K153048AcceleDent AuraOrthoaccel Technologies, Inc.K130643ACCELEDENT AURAOrthoaccel Technologies, Inc.

Official Source

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

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