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FDA 510(k)

ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH

K-Number: K941243 · 1994-06-06

ApplicantOraline, Ltd.
Decision Date1994-06-06
Product CodeJEQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Oraline, Ltd.. It received FDA 510(k) clearance on 1994-06-06 under 510(k) number K941243. 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 ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH?

ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH is a medical device that received FDA 510(k) clearance on 1994-06-06. The listed applicant is Oraline, Ltd.. The 510(k) number is K941243.

When did ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH receive FDA 510(k) clearance?

ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH received FDA 510(k) clearance on 1994-06-06, under 510(k) number K941243.

Who is the listed applicant for ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH?

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

What is the FDA product code for ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH?

The FDA product code for ORALSPRING PLUS BATTERY-POWERED TOOTHBRUSH is JEQ.

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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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