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FDA 510(k)

ULTRASONIC DENTURE CLEANER

K-Number: K881391 · 1988-08-26

ApplicantTatung Company of America, Inc.
Decision Date1988-08-26
Product CodeJER
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRASONIC DENTURE CLEANER is the device name listed in this FDA 510(k) record. The listed applicant is Tatung Company of America, Inc.. It received FDA 510(k) clearance on 1988-08-26 under 510(k) number K881391. 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 ULTRASONIC DENTURE CLEANER?

ULTRASONIC DENTURE CLEANER is a medical device that received FDA 510(k) clearance on 1988-08-26. The listed applicant is Tatung Company of America, Inc.. The 510(k) number is K881391.

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

ULTRASONIC DENTURE CLEANER received FDA 510(k) clearance on 1988-08-26, under 510(k) number K881391.

Who is the listed applicant for ULTRASONIC DENTURE CLEANER?

The FDA 510(k) record lists Tatung Company of America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASONIC DENTURE CLEANER?

The FDA product code for ULTRASONIC DENTURE CLEANER is JER.

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Other records listing Tatung Company of America, Inc. 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.

K874805TATUNG'S DENTURE CLEANING SOLUTION

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.K872521DENTURE CLEANSERSDental Research LaboratoriesK852906DURACLEAN DENTURE CLEANERAstron Dental Corp.K840805ORAL 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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