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FDA 510(k)

AONGEN DENTAL COLLAGEN MATRIX

K-Number: K112568 · 2012-03-01

ApplicantAeon Astron Europe B.V.
Decision Date2012-03-01
Product CodeOLR
DecisionSubstantially Equivalent

Device Summary

AONGEN DENTAL COLLAGEN MATRIX is the device name listed in this FDA 510(k) record. The listed applicant is Aeon Astron Europe B.V.. It received FDA 510(k) clearance on 2012-03-01 under 510(k) number K112568. The device is classified under product code OLR. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AONGEN DENTAL COLLAGEN MATRIX?

AONGEN DENTAL COLLAGEN MATRIX is a medical device that received FDA 510(k) clearance on 2012-03-01. The listed applicant is Aeon Astron Europe B.V.. The 510(k) number is K112568.

When did AONGEN DENTAL COLLAGEN MATRIX receive FDA 510(k) clearance?

AONGEN DENTAL COLLAGEN MATRIX received FDA 510(k) clearance on 2012-03-01, under 510(k) number K112568.

Who is the listed applicant for AONGEN DENTAL COLLAGEN MATRIX?

The FDA 510(k) record lists Aeon Astron Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AONGEN DENTAL COLLAGEN MATRIX?

The FDA product code for AONGEN DENTAL COLLAGEN MATRIX is OLR.

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 Aeon Astron Europe B.V. 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.

K173223ologen Collagen MatrixK080868AONGEN COLLAGEN MATRIX

Related Devices (Code: OLR)

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.

K260120NaturaJel™ Oral Wound Care KitHCS Innovation, LLCK251908Emanate TrayEmanate BiomedicalK260126Curajel™ Oral GelUSpharma, Ltd.K253816MuCover (proposed name) Oral Wound DressingMoleculeX Co., Ltd.K253758Dental Cone; Dental SpongeMedizin Produkte Neustadt GmbH (Mpn)K252425Silatrix Oral GelSa3, LLC

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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