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FDA 510(k)

Light Cure Adhesive

K-Number: K241056 · 2024-07-16

ApplicantSincera Technology (Changchun) Co., Ltd.
Decision Date2024-07-16
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Light Cure Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Sincera Technology (Changchun) Co., Ltd.. It received FDA 510(k) clearance on 2024-07-16 under 510(k) number K241056. 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 Light Cure Adhesive?

Light Cure Adhesive is a medical device that received FDA 510(k) clearance on 2024-07-16. The listed applicant is Sincera Technology (Changchun) Co., Ltd.. The 510(k) number is K241056.

When did Light Cure Adhesive receive FDA 510(k) clearance?

Light Cure Adhesive received FDA 510(k) clearance on 2024-07-16, under 510(k) number K241056.

Who is the listed applicant for Light Cure Adhesive?

The FDA 510(k) record lists Sincera Technology (Changchun) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Light Cure Adhesive?

The FDA product code for Light Cure Adhesive is KLE.

Other records listing Sincera Technology (Changchun) Co., Ltd. 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.

K240112Light Cure 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.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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