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FDA 510(k)

GLUMA DESENSITIZER/GLUMA 3 PRIMER

K-Number: K962812 · 1996-10-07

ApplicantHeraeus Kulzer, Inc.
Decision Date1996-10-07
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLUMA DESENSITIZER/GLUMA 3 PRIMER 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 1996-10-07 under 510(k) number K962812. 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 DESENSITIZER/GLUMA 3 PRIMER?

GLUMA DESENSITIZER/GLUMA 3 PRIMER is a medical device that received FDA 510(k) clearance on 1996-10-07. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K962812.

When did GLUMA DESENSITIZER/GLUMA 3 PRIMER receive FDA 510(k) clearance?

GLUMA DESENSITIZER/GLUMA 3 PRIMER received FDA 510(k) clearance on 1996-10-07, under 510(k) number K962812.

Who is the listed applicant for GLUMA DESENSITIZER/GLUMA 3 PRIMER?

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 DESENSITIZER/GLUMA 3 PRIMER?

The FDA product code for GLUMA DESENSITIZER/GLUMA 3 PRIMER is KLE.

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Other records listing Heraeus Kulzer, 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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