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FDA 510(k)

APEX UNIVERSAL ADHESIVE

K-Number: K131043 · 2013-09-10

ApplicantApex Dental Materials, Inc.
Decision Date2013-09-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

APEX UNIVERSAL ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Apex Dental Materials, Inc.. It received FDA 510(k) clearance on 2013-09-10 under 510(k) number K131043. 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 APEX UNIVERSAL ADHESIVE?

APEX UNIVERSAL ADHESIVE is a medical device that received FDA 510(k) clearance on 2013-09-10. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K131043.

When did APEX UNIVERSAL ADHESIVE receive FDA 510(k) clearance?

APEX UNIVERSAL ADHESIVE received FDA 510(k) clearance on 2013-09-10, under 510(k) number K131043.

Who is the listed applicant for APEX UNIVERSAL ADHESIVE?

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

What is the FDA product code for APEX UNIVERSAL ADHESIVE?

The FDA product code for APEX UNIVERSAL ADHESIVE is KLE.

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Other records listing Apex Dental Materials, Inc. 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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