Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ACCELEDENT AURA

K-Number: K130643 · 2013-04-23

ApplicantOrthoaccel Technologies, Inc.
Decision Date2013-04-23
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 2013-04-23 under 510(k) number K130643. 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 2013-04-23. The listed applicant is Orthoaccel Technologies, Inc.. The 510(k) number is K130643.

When did ACCELEDENT AURA receive FDA 510(k) clearance?

ACCELEDENT AURA received FDA 510(k) clearance on 2013-04-23, under 510(k) number K130643.

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 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 AuraK110661ACCELEDENT

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.K110661ACCELEDENTOrthoaccel 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.

↑