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FDA 510(k)

FL BOND II

K-Number: K071452 · 2007-07-09

ApplicantShofu Dental Corp.
Decision Date2007-07-09
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FL BOND II is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 2007-07-09 under 510(k) number K071452. 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 FL BOND II?

FL BOND II is a medical device that received FDA 510(k) clearance on 2007-07-09. The listed applicant is Shofu Dental Corp.. The 510(k) number is K071452.

When did FL BOND II receive FDA 510(k) clearance?

FL BOND II received FDA 510(k) clearance on 2007-07-09, under 510(k) number K071452.

Who is the listed applicant for FL BOND II?

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

What is the FDA product code for FL BOND II?

The FDA product code for FL BOND II is KLE.

Other records listing Shofu Dental Corp. 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.

K111855HY-BOND RESIGLASSK110252BEAUTIBOND MULTI PR PLUSK110235BEAUTIBOND MULTIK101603BEAUTIFIL FLOW PLUSK101621LITE ARTK093559VINTAGE MP

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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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