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FDA 510(k)

GENERATION 8 SE ADHESIVE

K-Number: K072480 · 2007-11-21

ApplicantPentron Clinical Technologies
Decision Date2007-11-21
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GENERATION 8 SE ADHESIVE 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 2007-11-21 under 510(k) number K072480. 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 GENERATION 8 SE ADHESIVE?

GENERATION 8 SE ADHESIVE is a medical device that received FDA 510(k) clearance on 2007-11-21. The listed applicant is Pentron Clinical Technologies. The 510(k) number is K072480.

When did GENERATION 8 SE ADHESIVE receive FDA 510(k) clearance?

GENERATION 8 SE ADHESIVE received FDA 510(k) clearance on 2007-11-21, under 510(k) number K072480.

Who is the listed applicant for GENERATION 8 SE ADHESIVE?

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 GENERATION 8 SE ADHESIVE?

The FDA product code for GENERATION 8 SE ADHESIVE 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 J032K072545ARTISTE SE FLOWABLE COMPOSITE, MODEL N280K071500NANO-BOND II ADHESIVE SYSTEMK060889SE 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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