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FDA 510(k)

TUBULITEC LINER

K-Number: K851053 · 1985-07-25

ApplicantDental Therapeutics AB
Decision Date1985-07-25
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TUBULITEC LINER is the device name listed in this FDA 510(k) record. The listed applicant is Dental Therapeutics AB. It received FDA 510(k) clearance on 1985-07-25 under 510(k) number K851053. 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 TUBULITEC LINER?

TUBULITEC LINER is a medical device that received FDA 510(k) clearance on 1985-07-25. The listed applicant is Dental Therapeutics AB. The 510(k) number is K851053.

When did TUBULITEC LINER receive FDA 510(k) clearance?

TUBULITEC LINER received FDA 510(k) clearance on 1985-07-25, under 510(k) number K851053.

Who is the listed applicant for TUBULITEC LINER?

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

What is the FDA product code for TUBULITEC LINER?

The FDA product code for TUBULITEC LINER is EJK.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dental Therapeutics AB 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.

K851052TUBULITEC PRIMER

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.K253248Bright Cavity LinerDmp Dental Industry S.A.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 GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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