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FDA 510(k)

BOND-1 C & B

K-Number: K013543 · 2002-02-22

ApplicantJeneric/Pentron, Inc.
Decision Date2002-02-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BOND-1 C & B is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 2002-02-22 under 510(k) number K013543. 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 BOND-1 C & B?

BOND-1 C & B is a medical device that received FDA 510(k) clearance on 2002-02-22. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K013543.

When did BOND-1 C & B receive FDA 510(k) clearance?

BOND-1 C & B received FDA 510(k) clearance on 2002-02-22, under 510(k) number K013543.

Who is the listed applicant for BOND-1 C & B?

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

What is the FDA product code for BOND-1 C & B?

The FDA product code for BOND-1 C & B is KLE.

Other records listing Jeneric/Pentron, 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.

K020499BOND-3 ADHESIVEK013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)K012231AVANTE MICRO CRYSTAL SYSTEMK011748FIRST FILL R.C.S.K010957QUELL DESENSITIZERK011331JP CAST 40

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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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