FDA 510(k)

PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER

K-Number: K884918 · 1989-02-13

Decision Date1989-02-13

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER is the device name listed in this FDA 510(k) record. The listed applicant is Parkell. It received FDA 510(k) clearance on 1989-02-13 under 510(k) number K884918. 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 PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER?

PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER is a medical device that received FDA 510(k) clearance on 1989-02-13. The listed applicant is Parkell. The 510(k) number is K884918.

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

PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER received FDA 510(k) clearance on 1989-02-13, under 510(k) number K884918.

Who is the listed applicant for PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER?

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

What is the FDA product code for PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER?

The FDA product code for PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER is KLE.

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Related Devices (Code: KLE)

K262252MPa Max adhesiveDen-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products Company K251587VITA 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.