FDA 510(k)

ETCH GEL

K-Number: K131248 · 2013-07-11

Decision Date2013-07-11

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ETCH GEL is the device name listed in this FDA 510(k) record. The listed applicant is Dmg America, LLC. It received FDA 510(k) clearance on 2013-07-11 under 510(k) number K131248. 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 GEL?

ETCH GEL is a medical device that received FDA 510(k) clearance on 2013-07-11. The listed applicant is Dmg America, LLC. The 510(k) number is K131248.

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

ETCH GEL received FDA 510(k) clearance on 2013-07-11, under 510(k) number K131248.

Who is the listed applicant for ETCH GEL?

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

What is the FDA product code for ETCH GEL?

The FDA product code for ETCH GEL is KLE.

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, 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.