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FDA 510(k)

DURAFILL BOND

K-Number: K921701 · 1992-06-09

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-06-09
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DURAFILL BOND is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-06-09 under 510(k) number K921701. 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 DURAFILL BOND?

DURAFILL BOND is a medical device that received FDA 510(k) clearance on 1992-06-09. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K921701.

When did DURAFILL BOND receive FDA 510(k) clearance?

DURAFILL BOND received FDA 510(k) clearance on 1992-06-09, under 510(k) number K921701.

Who is the listed applicant for DURAFILL BOND?

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

What is the FDA product code for DURAFILL BOND?

The FDA product code for DURAFILL BOND is KLE.

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Other records listing Heraeus Kulzer, Inc. 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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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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