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FDA 510(k)

OPTIBOND FL

K-Number: K031444 · 2003-07-02

ApplicantKerr Dental Materials Center
Decision Date2003-07-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIBOND FL is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Dental Materials Center. It received FDA 510(k) clearance on 2003-07-02 under 510(k) number K031444. 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 FL?

OPTIBOND FL is a medical device that received FDA 510(k) clearance on 2003-07-02. The listed applicant is Kerr Dental Materials Center. The 510(k) number is K031444.

When did OPTIBOND FL receive FDA 510(k) clearance?

OPTIBOND FL received FDA 510(k) clearance on 2003-07-02, under 510(k) number K031444.

Who is the listed applicant for OPTIBOND FL?

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

What is the FDA product code for OPTIBOND FL?

The FDA product code for OPTIBOND FL is KLE.

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Other records listing Kerr Dental Materials Center 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.

K050984BIOPLANTK030646BELLEGLASS POINT 4K020303XR PRIMER 2K020178BELLEGLASS HP MODELING GELK020092TEMPHASEK014027OPTIBOND SOLO PLUS 4

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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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