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FDA 510(k)

IONODENT II (6 VOLTS)

K-Number: K883761 · 1988-12-05

ApplicantU.S. Apatite Corp.
Decision Date1988-12-05
Product CodeEFW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IONODENT II (6 VOLTS) is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Apatite Corp.. It received FDA 510(k) clearance on 1988-12-05 under 510(k) number K883761. The device is classified under product code EFW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IONODENT II (6 VOLTS)?

IONODENT II (6 VOLTS) is a medical device that received FDA 510(k) clearance on 1988-12-05. The listed applicant is U.S. Apatite Corp.. The 510(k) number is K883761.

When did IONODENT II (6 VOLTS) receive FDA 510(k) clearance?

IONODENT II (6 VOLTS) received FDA 510(k) clearance on 1988-12-05, under 510(k) number K883761.

Who is the listed applicant for IONODENT II (6 VOLTS)?

The FDA 510(k) record lists U.S. Apatite Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IONODENT II (6 VOLTS)?

The FDA product code for IONODENT II (6 VOLTS) is EFW.

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 U.S. Apatite Corp. 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.

K874443IONODENT (TOOTHBRUSH)

Related Devices (Code: EFW)

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.

K130186DENTEK EASY BRUSH WITH FLUORIDEDen Tek Oral Care, Inc.K121165BEAM BRUSH/BEAM APPBeam Technologies, LLCK102871SILVER CARE ANITBACTERIAL TOOTHBRUSHPiave Spazzolificio S.P.A.K073224ORAL-B SUB-BRAND MANUAL TOOTHBRUSHProcter & GambleK021383ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIALAgion Technologies, LLCK020776MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTSCoronet Group North America, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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