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FDA 510(k)

ROTA-DENT TOOTH CLEANER

K-Number: K880589 · 1988-05-11

ApplicantPro-Dentec
Decision Date1988-05-11
Product CodeJEQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROTA-DENT TOOTH CLEANER is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Dentec. It received FDA 510(k) clearance on 1988-05-11 under 510(k) number K880589. The device is classified under product code JEQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTA-DENT TOOTH CLEANER?

ROTA-DENT TOOTH CLEANER is a medical device that received FDA 510(k) clearance on 1988-05-11. The listed applicant is Pro-Dentec. The 510(k) number is K880589.

When did ROTA-DENT TOOTH CLEANER receive FDA 510(k) clearance?

ROTA-DENT TOOTH CLEANER received FDA 510(k) clearance on 1988-05-11, under 510(k) number K880589.

Who is the listed applicant for ROTA-DENT TOOTH CLEANER?

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

What is the FDA product code for ROTA-DENT TOOTH CLEANER?

The FDA product code for ROTA-DENT TOOTH CLEANER is JEQ.

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.

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Other records listing Pro-Dentec 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.

K960245VIP VICTOR INTERACTIVE PROBE

Related Devices (Code: JEQ)

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.

K200881Oral-B iO Test Drive Power Brush Trial Program KitThe Procter & Gamble CompanyK061351ORAL-B SONIC COMPLETEBraun GmbHK061199ORAL B PROFESSIONALCARE SERIES, ORAL B ADVANCEPOWER SERIESBraun GmbHK040416SONICARE ADVANCE TOOTHBRUSH, MODEL 4900Philips Oral Healthcare, Inc.K022900BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHESJohn O. Butler Co.K012914SONICWAVE SONIC PLAQUE REMOVERHomedics, 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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