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FDA 510(k)

Peak Universal Bond

K-Number: K240743 · 2024-03-20

ApplicantUltradent Products, Inc.
Decision Date2024-03-20
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Peak Universal Bond is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2024-03-20 under 510(k) number K240743. 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 Peak Universal Bond?

Peak Universal Bond is a medical device that received FDA 510(k) clearance on 2024-03-20. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K240743.

When did Peak Universal Bond receive FDA 510(k) clearance?

Peak Universal Bond received FDA 510(k) clearance on 2024-03-20, under 510(k) number K240743.

Who is the listed applicant for Peak Universal Bond?

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

What is the FDA product code for Peak Universal Bond?

The FDA product code for Peak Universal Bond is KLE.

Other records listing Ultradent Products, 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.

K260485Any-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.K252151els unibondSaremco Dental AG

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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