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FDA 510(k)

Bright Cavity Liner

K-Number: K253248 · 2026-01-13

ApplicantDmp Dental Industry S.A.
Decision Date2026-01-13
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bright Cavity Liner is the device name listed in this FDA 510(k) record. The listed applicant is Dmp Dental Industry S.A.. It received FDA 510(k) clearance on 2026-01-13 under 510(k) number K253248. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bright Cavity Liner?

Bright Cavity Liner is a medical device that received FDA 510(k) clearance on 2026-01-13. The listed applicant is Dmp Dental Industry S.A.. The 510(k) number is K253248.

When did Bright Cavity Liner receive FDA 510(k) clearance?

Bright Cavity Liner received FDA 510(k) clearance on 2026-01-13, under 510(k) number K253248.

Who is the listed applicant for Bright Cavity Liner?

The FDA 510(k) record lists Dmp Dental Industry S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bright Cavity Liner?

The FDA product code for Bright Cavity Liner is EJK.

Other records listing Dmp Dental Industry S.A. 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.

K252469MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCAK192830Bright Temporary C&B

Related Devices (Code: EJK)

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.

K261728One-Fil LCMediclus Co., Ltd.K2302703M™ VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbHK191103Parkell Desensitizer GelParkell, Inc.

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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