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FDA 510(k)

COLLACARE DENTAL

K-Number: K110388 · 2011-08-09

ApplicantInnocoll Pharmaceuticals, Ltd.
Decision Date2011-08-09
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

COLLACARE DENTAL is the device name listed in this FDA 510(k) record. The listed applicant is Innocoll Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 2011-08-09 under 510(k) number K110388. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLLACARE DENTAL?

COLLACARE DENTAL is a medical device that received FDA 510(k) clearance on 2011-08-09. The listed applicant is Innocoll Pharmaceuticals, Ltd.. The 510(k) number is K110388.

When did COLLACARE DENTAL receive FDA 510(k) clearance?

COLLACARE DENTAL received FDA 510(k) clearance on 2011-08-09, under 510(k) number K110388.

Who is the listed applicant for COLLACARE DENTAL?

The FDA 510(k) record lists Innocoll Pharmaceuticals, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLLACARE DENTAL?

The FDA product code for COLLACARE DENTAL is KGN.

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Other records listing Innocoll Pharmaceuticals, Ltd. 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.

K103648COLLAGEN POWDER

Related Devices (Code: KGN)

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.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, 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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