Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bond-PR™ Universal Adhesive

K-Number: K260682 · 2026-03-03

ApplicantPremier Dental Products Company
Decision Date2026-03-03
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bond-PR™ Universal Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Company. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K260682. 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 Bond-PR™ Universal Adhesive?

Bond-PR™ Universal Adhesive is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Premier Dental Products Company. The 510(k) number is K260682.

When did Bond-PR™ Universal Adhesive receive FDA 510(k) clearance?

Bond-PR™ Universal Adhesive received FDA 510(k) clearance on 2026-03-03, under 510(k) number K260682.

Who is the listed applicant for Bond-PR™ Universal Adhesive?

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

What is the FDA product code for Bond-PR™ Universal Adhesive?

The FDA product code for Bond-PR™ Universal Adhesive is KLE.

Related Clinical Trials

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.

NCT04604314Alternative EndoCrowns Designs for Chairside CAD/CAMCOMPLETEDNCT076337173-D Printed Resin Composite Versus Milled Resin Composite and Hybrid Ceramic Onlays: 2-Year Clinical Performance, Microtensile Bond Strength, Marginal and Internal AdaptationACTIVE_NOT_RECRUITINGNCT07731061Clinical Performance of Two HEMA-Free Universal Adhesive SystemsNOT_YET_RECRUITING

Other records listing Premier Dental Products Company 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.

K253513MultiMatch Flow Chameleon AntiMicrobial CompositeK223632Premier's MultiMatch Universal Chameleon Restorative Composite

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.K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AGK252469MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCADmp Dental Industry S.A.

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.

↑