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FDA 510(k)

COLTENE A.R.T. BOND

K-Number: K922615 · 1992-08-03

ApplicantColtene/Whaledent, Inc.
Decision Date1992-08-03
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTENE A.R.T. BOND is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 1992-08-03 under 510(k) number K922615. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLTENE A.R.T. BOND?

COLTENE A.R.T. BOND is a medical device that received FDA 510(k) clearance on 1992-08-03. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K922615.

When did COLTENE A.R.T. BOND receive FDA 510(k) clearance?

COLTENE A.R.T. BOND received FDA 510(k) clearance on 1992-08-03, under 510(k) number K922615.

Who is the listed applicant for COLTENE A.R.T. BOND?

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

What is the FDA product code for COLTENE A.R.T. BOND?

The FDA product code for COLTENE A.R.T. BOND is KLE.

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Other records listing Coltene/Whaledent, 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.

K071632PERFECT TISSUE CONTOURING SYSTEM IIK051660DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEMK040551COLTOLUX LED CURING LIGHTK033760ONE COAT SE BONDK031752COLTOSOL FK013400SYNERGY FLOW

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Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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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