Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

REACH ANTIBACTERIAL TOOTHBRUSH

K-Number: K971589 · 1997-07-24

ApplicantPersonal Products Co.
Decision Date1997-07-24
Product CodeEFW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REACH ANTIBACTERIAL TOOTHBRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Personal Products Co.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K971589. 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 REACH ANTIBACTERIAL TOOTHBRUSH?

REACH ANTIBACTERIAL TOOTHBRUSH is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Personal Products Co.. The 510(k) number is K971589.

When did REACH ANTIBACTERIAL TOOTHBRUSH receive FDA 510(k) clearance?

REACH ANTIBACTERIAL TOOTHBRUSH received FDA 510(k) clearance on 1997-07-24, under 510(k) number K971589.

Who is the listed applicant for REACH ANTIBACTERIAL TOOTHBRUSH?

The FDA 510(k) record lists Personal Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REACH ANTIBACTERIAL TOOTHBRUSH?

The FDA product code for REACH ANTIBACTERIAL TOOTHBRUSH 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Personal Products Co. 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.

K070545K-Y BRAND WARMING LIQUIDK062796K-Y BRAND INTRIGUEK010365ORTHO CONTROL FEMALE URINARY CONTROL DEVICEK990536O.B. TAMPONK991118O.B. APPLICATOR TAMPONS, O.B. TAMPONSK974629O.B. APPLICATOR AND NON-APPLICATOR TAMPONS

View all 45 devices →

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

View on FDA Database →

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

↑