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)

One Coat Bond; One Coat Bond SL

K-Number: K263680 · 2026-10-08

ApplicantDent4You AG
Decision Date2026-10-08
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

One Coat Bond; One Coat Bond SL is the device name listed in this FDA 510(k) record. The listed applicant is Dent4You AG. It received FDA 510(k) clearance on 2026-10-08 under 510(k) number K263680. 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 One Coat Bond; One Coat Bond SL?

One Coat Bond; One Coat Bond SL is a medical device that received FDA 510(k) clearance on 2026-10-08. The listed applicant is Dent4You AG. The 510(k) number is K263680.

When did One Coat Bond; One Coat Bond SL receive FDA 510(k) clearance?

One Coat Bond; One Coat Bond SL received FDA 510(k) clearance on 2026-10-08, under 510(k) number K263680.

Who is the listed applicant for One Coat Bond; One Coat Bond SL?

The FDA 510(k) record lists Dent4You AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for One Coat Bond; One Coat Bond SL?

The FDA product code for One Coat Bond; One Coat Bond SL is KLE.

Other records listing Dent4You AG 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.

K250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTK242360Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal ActivatorK240801BioSonic US200 Ultrasonic Scaler (60034537)K223142Coltolux Comfort LED Curing Light

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.

↑