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FDA 510(k)

EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT

K-Number: K032953 · 2003-12-10

ApplicantPulpdent Corporation
Decision Date2003-12-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2003-12-10 under 510(k) number K032953. 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 EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT?

EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT is a medical device that received FDA 510(k) clearance on 2003-12-10. The listed applicant is Pulpdent Corporation. The 510(k) number is K032953.

When did EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT receive FDA 510(k) clearance?

EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT received FDA 510(k) clearance on 2003-12-10, under 510(k) number K032953.

Who is the listed applicant for EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT?

The FDA 510(k) record lists Pulpdent Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT?

The FDA product code for EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT is KLE.

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Other records listing Pulpdent Corporation 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.

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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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