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FDA 510(k)

KERR OPTIBOND, MODIFICATION

K-Number: K934690 · 1993-12-30

ApplicantKerr Corporation (Danbury)
Decision Date1993-12-30
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KERR OPTIBOND, MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation (Danbury). It received FDA 510(k) clearance on 1993-12-30 under 510(k) number K934690. 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 OPTIBOND, MODIFICATION?

KERR OPTIBOND, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-12-30. The listed applicant is Kerr Corporation (Danbury). The 510(k) number is K934690.

When did KERR OPTIBOND, MODIFICATION receive FDA 510(k) clearance?

KERR OPTIBOND, MODIFICATION received FDA 510(k) clearance on 1993-12-30, under 510(k) number K934690.

Who is the listed applicant for KERR OPTIBOND, MODIFICATION?

The FDA 510(k) record lists Kerr Corporation (Danbury) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KERR OPTIBOND, MODIFICATION?

The FDA product code for KERR OPTIBOND, MODIFICATION is KLE.

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Other records listing Kerr Corporation (Danbury) 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.

K051545L.E. DEMETRON IIK020091OPTILUX 501K951663TYTIN RK951511TYTIN ADMIXK942480M4 CONTRA-ANGLE HANDPIECEK940513OPTIBOND

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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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