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FDA 510(k)

ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM

K-Number: K974906 · 1998-03-24

ApplicantColtene/Whaledent, Inc.
Decision Date1998-03-24
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM 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 1998-03-24 under 510(k) number K974906. 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 ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM?

ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-03-24. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K974906.

When did ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM receive FDA 510(k) clearance?

ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM received FDA 510(k) clearance on 1998-03-24, under 510(k) number K974906.

Who is the listed applicant for ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM?

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 ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM?

The FDA product code for ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM 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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