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FDA 510(k)

KERR NEXUS ONE BOTTLE ADHESIVE

K-Number: K972858 · 1997-09-26

ApplicantSybron Dental Specialties, Inc.
Decision Date1997-09-26
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KERR NEXUS ONE BOTTLE ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1997-09-26 under 510(k) number K972858. 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 KERR NEXUS ONE BOTTLE ADHESIVE?

KERR NEXUS ONE BOTTLE ADHESIVE is a medical device that received FDA 510(k) clearance on 1997-09-26. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K972858.

When did KERR NEXUS ONE BOTTLE ADHESIVE receive FDA 510(k) clearance?

KERR NEXUS ONE BOTTLE ADHESIVE received FDA 510(k) clearance on 1997-09-26, under 510(k) number K972858.

Who is the listed applicant for KERR NEXUS ONE BOTTLE ADHESIVE?

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

What is the FDA product code for KERR NEXUS ONE BOTTLE ADHESIVE?

The FDA product code for KERR NEXUS ONE BOTTLE ADHESIVE is KLE.

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Other records listing Sybron Dental Specialties, 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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