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FDA 510(k)

TOKUYAMA ONE-UP-BOND F

K-Number: K993917 · 2000-02-02

ApplicantTokuyama America, Inc.
Decision Date2000-02-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TOKUYAMA ONE-UP-BOND F is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama America, Inc.. It received FDA 510(k) clearance on 2000-02-02 under 510(k) number K993917. 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 TOKUYAMA ONE-UP-BOND F?

TOKUYAMA ONE-UP-BOND F is a medical device that received FDA 510(k) clearance on 2000-02-02. The listed applicant is Tokuyama America, Inc.. The 510(k) number is K993917.

When did TOKUYAMA ONE-UP-BOND F receive FDA 510(k) clearance?

TOKUYAMA ONE-UP-BOND F received FDA 510(k) clearance on 2000-02-02, under 510(k) number K993917.

Who is the listed applicant for TOKUYAMA ONE-UP-BOND F?

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

What is the FDA product code for TOKUYAMA ONE-UP-BOND F?

The FDA product code for TOKUYAMA ONE-UP-BOND F is KLE.

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Other records listing Tokuyama America, Inc. 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.

K022641TOKUYAMA REBASE IIK011854TOKUYAMA M-BONDK011685BISTITE II DCK010267PALFIQUE ESTELITE LV CLEARK002863PALFIQUE ESTELITE LVK991711BISTITE II SC

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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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