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FDA 510(k)

COMPOSITE/COMPOMER REPAIR KIT

K-Number: K041960 · 2004-08-30

ApplicantDmg USA, Inc.
Decision Date2004-08-30
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMPOSITE/COMPOMER REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2004-08-30 under 510(k) number K041960. 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 COMPOSITE/COMPOMER REPAIR KIT?

COMPOSITE/COMPOMER REPAIR KIT is a medical device that received FDA 510(k) clearance on 2004-08-30. The listed applicant is Dmg USA, Inc.. The 510(k) number is K041960.

When did COMPOSITE/COMPOMER REPAIR KIT receive FDA 510(k) clearance?

COMPOSITE/COMPOMER REPAIR KIT received FDA 510(k) clearance on 2004-08-30, under 510(k) number K041960.

Who is the listed applicant for COMPOSITE/COMPOMER REPAIR KIT?

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

What is the FDA product code for COMPOSITE/COMPOMER REPAIR KIT?

The FDA product code for COMPOSITE/COMPOMER REPAIR KIT is KLE.

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Other records listing Dmg USA, 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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