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FDA 510(k)

DENTIN CONDITIONING AND ADHESIVE SYSTEM

K-Number: K936222 · 1994-03-15

ApplicantJeneric/Pentron, Inc.
Decision Date1994-03-15
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTIN CONDITIONING AND ADHESIVE SYSTEM 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 1994-03-15 under 510(k) number K936222. 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 DENTIN CONDITIONING AND ADHESIVE SYSTEM?

DENTIN CONDITIONING AND ADHESIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-15. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K936222.

When did DENTIN CONDITIONING AND ADHESIVE SYSTEM receive FDA 510(k) clearance?

DENTIN CONDITIONING AND ADHESIVE SYSTEM received FDA 510(k) clearance on 1994-03-15, under 510(k) number K936222.

Who is the listed applicant for DENTIN CONDITIONING AND ADHESIVE SYSTEM?

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 DENTIN CONDITIONING AND ADHESIVE SYSTEM?

The FDA product code for DENTIN CONDITIONING AND ADHESIVE SYSTEM is KLE.

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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 ADHESIVEK013543BOND-1 C & BK013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)K012231AVANTE MICRO CRYSTAL SYSTEMK011748FIRST FILL R.C.S.K010957QUELL DESENSITIZER

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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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