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FDA 510(k)

OPTIBOND

K-Number: K940513 · 1994-04-15

ApplicantKerr Corporation (Danbury)
Decision Date1994-04-15
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIBOND 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 1994-04-15 under 510(k) number K940513. 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 OPTIBOND?

OPTIBOND is a medical device that received FDA 510(k) clearance on 1994-04-15. The listed applicant is Kerr Corporation (Danbury). The 510(k) number is K940513.

When did OPTIBOND receive FDA 510(k) clearance?

OPTIBOND received FDA 510(k) clearance on 1994-04-15, under 510(k) number K940513.

Who is the listed applicant for OPTIBOND?

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 OPTIBOND?

The FDA product code for OPTIBOND 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 HANDPIECEK935535TYTIN

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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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