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FDA 510(k)

DENTSPLY DENTURE CLEANER

K-Number: K800166 · 1980-03-17

ApplicantDentsply Intl.
Decision Date1980-03-17
Product CodeJER
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTSPLY DENTURE CLEANER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1980-03-17 under 510(k) number K800166. 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 DENTSPLY DENTURE CLEANER?

DENTSPLY DENTURE CLEANER is a medical device that received FDA 510(k) clearance on 1980-03-17. The listed applicant is Dentsply Intl.. The 510(k) number is K800166.

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

DENTSPLY DENTURE CLEANER received FDA 510(k) clearance on 1980-03-17, under 510(k) number K800166.

Who is the listed applicant for DENTSPLY DENTURE CLEANER?

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

What is the FDA product code for DENTSPLY DENTURE CLEANER?

The FDA product code for DENTSPLY DENTURE CLEANER is JER.

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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 LaboratoriesK852906DURACLEAN DENTURE CLEANERAstron Dental Corp.K840805ORAL SAFEGreat Lakes Orthodontics, Ltd.K832359ORAL SAFEGreat Lakes Orthodontics, 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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