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FDA 510(k)

TUBULITEC PRIMER

K-Number: K851052 · 1985-07-31

ApplicantDental Therapeutics AB
Decision Date1985-07-31
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TUBULITEC PRIMER 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 1985-07-31 under 510(k) number K851052. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUBULITEC PRIMER?

TUBULITEC PRIMER is a medical device that received FDA 510(k) clearance on 1985-07-31. The listed applicant is Dental Therapeutics AB. The 510(k) number is K851052.

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

TUBULITEC PRIMER received FDA 510(k) clearance on 1985-07-31, under 510(k) number K851052.

Who is the listed applicant for TUBULITEC PRIMER?

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 PRIMER?

The FDA product code for TUBULITEC PRIMER is LBH.

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.

K851053TUBULITEC LINER

Related Devices (Code: LBH)

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.

K262243Profisil FreeKettenbach GmbH & Co. KGK253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, 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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