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FDA 510(k)

GLUMA COMFORT BOND + DESENSITIZER

K-Number: K992292 · 1999-10-01

ApplicantHeraeus Kulzer, Inc.
Decision Date1999-10-01
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLUMA COMFORT BOND + DESENSITIZER 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 1999-10-01 under 510(k) number K992292. 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 GLUMA COMFORT BOND + DESENSITIZER?

GLUMA COMFORT BOND + DESENSITIZER is a medical device that received FDA 510(k) clearance on 1999-10-01. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K992292.

When did GLUMA COMFORT BOND + DESENSITIZER receive FDA 510(k) clearance?

GLUMA COMFORT BOND + DESENSITIZER received FDA 510(k) clearance on 1999-10-01, under 510(k) number K992292.

Who is the listed applicant for GLUMA COMFORT BOND + DESENSITIZER?

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 GLUMA COMFORT BOND + DESENSITIZER?

The FDA product code for GLUMA COMFORT BOND + DESENSITIZER 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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