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FDA 510(k)

DURACLEAN DENTURE CLEANER

K-Number: K852906 · 1985-07-31

ApplicantAstron Dental Corp.
Decision Date1985-07-31
Product CodeJER
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DURACLEAN DENTURE CLEANER is the device name listed in this FDA 510(k) record. The listed applicant is Astron Dental Corp.. It received FDA 510(k) clearance on 1985-07-31 under 510(k) number K852906. The device is classified under product code JER. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURACLEAN DENTURE CLEANER?

DURACLEAN DENTURE CLEANER is a medical device that received FDA 510(k) clearance on 1985-07-31. The listed applicant is Astron Dental Corp.. The 510(k) number is K852906.

When did DURACLEAN DENTURE CLEANER receive FDA 510(k) clearance?

DURACLEAN DENTURE CLEANER received FDA 510(k) clearance on 1985-07-31, under 510(k) number K852906.

Who is the listed applicant for DURACLEAN DENTURE CLEANER?

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

What is the FDA product code for DURACLEAN DENTURE CLEANER?

The FDA product code for DURACLEAN DENTURE CLEANER is JER.

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 Astron Dental Corp. 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.

K8740252ND MODIFIED VINYLAC PRESS PACK DENTURE RESINK864757MODIFIED VINYLAC PRESS PACK DENTURE RESINK833270ASTRON 77 INJECTION DENTURE RESINK831269VINYLAC PRESS-PACK DENTURE RESIN

Related Devices (Code: JER)

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.

K883403DENTA PLUSConnoisseurs Products Corp.K881391ULTRASONIC DENTURE CLEANERTatung Company of America, Inc.K872521DENTURE CLEANSERSDental Research LaboratoriesK840805ORAL SAFEGreat Lakes Orthodontics, Ltd.K832359ORAL SAFEGreat Lakes Orthodontics, Ltd.K832387DENTURE CLEANERTower Laboratories, Ltd.

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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