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FDA 510(k)

PLUSTRON ION TOOTHBRUSH SYSTEM

K-Number: K971639 · 1997-06-24

ApplicantSas Group, Inc.
Decision Date1997-06-24
Product CodeMMD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PLUSTRON ION TOOTHBRUSH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sas Group, Inc.. It received FDA 510(k) clearance on 1997-06-24 under 510(k) number K971639. The device is classified under product code MMD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLUSTRON ION TOOTHBRUSH SYSTEM?

PLUSTRON ION TOOTHBRUSH SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-24. The listed applicant is Sas Group, Inc.. The 510(k) number is K971639.

When did PLUSTRON ION TOOTHBRUSH SYSTEM receive FDA 510(k) clearance?

PLUSTRON ION TOOTHBRUSH SYSTEM received FDA 510(k) clearance on 1997-06-24, under 510(k) number K971639.

Who is the listed applicant for PLUSTRON ION TOOTHBRUSH SYSTEM?

The FDA 510(k) record lists Sas Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PLUSTRON ION TOOTHBRUSH SYSTEM?

The FDA product code for PLUSTRON ION TOOTHBRUSH SYSTEM is MMD.

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Related Devices (Code: MMD)

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.

K915576HUBUKA HYG TOOTHBRUSHHukuba Dental Corp.

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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