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FDA 510(k)

XR PRIMER 2

K-Number: K020303 · 2002-04-19

ApplicantKerr Dental Materials Center
Decision Date2002-04-19
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XR PRIMER 2 is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Dental Materials Center. It received FDA 510(k) clearance on 2002-04-19 under 510(k) number K020303. 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 XR PRIMER 2?

XR PRIMER 2 is a medical device that received FDA 510(k) clearance on 2002-04-19. The listed applicant is Kerr Dental Materials Center. The 510(k) number is K020303.

When did XR PRIMER 2 receive FDA 510(k) clearance?

XR PRIMER 2 received FDA 510(k) clearance on 2002-04-19, under 510(k) number K020303.

Who is the listed applicant for XR PRIMER 2?

The FDA 510(k) record lists Kerr Dental Materials Center as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XR PRIMER 2?

The FDA product code for XR PRIMER 2 is KLE.

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Other records listing Kerr Dental Materials Center as applicant

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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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