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FDA 510(k)

NANO-BOND II ADHESIVE SYSTEM

K-Number: K071500 · 2007-08-10

ApplicantPentron Clinical Technologies
Decision Date2007-08-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NANO-BOND II ADHESIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Clinical Technologies. It received FDA 510(k) clearance on 2007-08-10 under 510(k) number K071500. 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 NANO-BOND II ADHESIVE SYSTEM?

NANO-BOND II ADHESIVE SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-10. The listed applicant is Pentron Clinical Technologies. The 510(k) number is K071500.

When did NANO-BOND II ADHESIVE SYSTEM receive FDA 510(k) clearance?

NANO-BOND II ADHESIVE SYSTEM received FDA 510(k) clearance on 2007-08-10, under 510(k) number K071500.

Who is the listed applicant for NANO-BOND II ADHESIVE SYSTEM?

The FDA 510(k) record lists Pentron Clinical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NANO-BOND II ADHESIVE SYSTEM?

The FDA product code for NANO-BOND II ADHESIVE SYSTEM is KLE.

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Other records listing Pentron Clinical Technologies 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.

K091512BUILD-IT LIGHT CUREK081887LUTE-IT II VENEER CEMENT, MODEL NO6K072830RM BOND, MODEL J032K072480GENERATION 8 SE ADHESIVEK072545ARTISTE SE FLOWABLE COMPOSITE, MODEL N280K060889SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE

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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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