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FDA 510(k)

HURRISEAL DENTIN DESENSITIZER

K-Number: K973002 · 1998-03-23

ApplicantCheng & Assoc., Inc.
Decision Date1998-03-23
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HURRISEAL DENTIN DESENSITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Cheng & Assoc., Inc.. It received FDA 510(k) clearance on 1998-03-23 under 510(k) number K973002. 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 HURRISEAL DENTIN DESENSITIZER?

HURRISEAL DENTIN DESENSITIZER is a medical device that received FDA 510(k) clearance on 1998-03-23. The listed applicant is Cheng & Assoc., Inc.. The 510(k) number is K973002.

When did HURRISEAL DENTIN DESENSITIZER receive FDA 510(k) clearance?

HURRISEAL DENTIN DESENSITIZER received FDA 510(k) clearance on 1998-03-23, under 510(k) number K973002.

Who is the listed applicant for HURRISEAL DENTIN DESENSITIZER?

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

What is the FDA product code for HURRISEAL DENTIN DESENSITIZER?

The FDA product code for HURRISEAL DENTIN DESENSITIZER is KLE.

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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

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

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