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FDA 510(k)

ETCH AND BOND

K-Number: K852660 · 1985-07-25

ApplicantDentsply Intl.
Decision Date1985-07-25
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ETCH AND BOND is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1985-07-25 under 510(k) number K852660. 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 ETCH AND BOND?

ETCH AND BOND is a medical device that received FDA 510(k) clearance on 1985-07-25. The listed applicant is Dentsply Intl.. The 510(k) number is K852660.

When did ETCH AND BOND receive FDA 510(k) clearance?

ETCH AND BOND received FDA 510(k) clearance on 1985-07-25, under 510(k) number K852660.

Who is the listed applicant for ETCH AND BOND?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETCH AND BOND?

The FDA product code for ETCH AND BOND is KLE.

Other records listing Dentsply Intl. 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.

K123615IRIS - HIGH STRENGTH GLASS CERAMICK072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTSK070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEK070019CARRARA VOLUMIAK061427PRE-IMPRESSION CONDITIONING SOLUTIONK052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131

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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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