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FDA 510(k)

ETCHING GEL

K-Number: K833718 · 1983-12-29

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1983-12-29
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ETCHING GEL is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1983-12-29 under 510(k) number K833718. 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 ETCHING GEL?

ETCHING GEL is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K833718.

When did ETCHING GEL receive FDA 510(k) clearance?

ETCHING GEL received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833718.

Who is the listed applicant for ETCHING GEL?

The FDA 510(k) record lists Johnson & Johnson Professionals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETCHING GEL?

The FDA product code for ETCHING GEL is KLE.

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Other records listing Johnson & Johnson Professionals, Inc. as applicant

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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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