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FDA 510(k)

PREMIER CERAMIC PRIMER

K-Number: K131212 · 2013-08-26

ApplicantPremier Dental Products Co.
Decision Date2013-08-26
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PREMIER CERAMIC PRIMER is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Co.. It received FDA 510(k) clearance on 2013-08-26 under 510(k) number K131212. 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 PREMIER CERAMIC PRIMER?

PREMIER CERAMIC PRIMER is a medical device that received FDA 510(k) clearance on 2013-08-26. The listed applicant is Premier Dental Products Co.. The 510(k) number is K131212.

When did PREMIER CERAMIC PRIMER receive FDA 510(k) clearance?

PREMIER CERAMIC PRIMER received FDA 510(k) clearance on 2013-08-26, under 510(k) number K131212.

Who is the listed applicant for PREMIER CERAMIC PRIMER?

The FDA 510(k) record lists Premier Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREMIER CERAMIC PRIMER?

The FDA product code for PREMIER CERAMIC PRIMER is KLE.

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Other records listing Premier Dental Products Co. 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.

K132526KNIT-PAK+K083695TRAXODENTK062166ENAMEL PROK062683ENAMEL PRO VARNISHK061998PREMIER SELF-ETCHING BOND ENHANCERK061997PREMIER SELF-ETCHING ENAMEL SEALANT

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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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