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)

ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM

K-Number: K901994 · 1990-07-31

ApplicantRosofsky & Ross, Inc.
Decision Date1990-07-31
Product CodeEFW
Advisory CommitteeDE
DecisionUnknown

Device Summary

ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Rosofsky & Ross, Inc.. It received FDA 510(k) clearance on 1990-07-31 under 510(k) number K901994. The device is classified under product code EFW. It was reviewed by the DE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM?

ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM is a medical device that received FDA 510(k) clearance on 1990-07-31. The listed applicant is Rosofsky & Ross, Inc.. The 510(k) number is K901994.

When did ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM receive FDA 510(k) clearance?

ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM received FDA 510(k) clearance on 1990-07-31, under 510(k) number K901994.

Who is the listed applicant for ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM?

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

What is the FDA product code for ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM?

The FDA product code for ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM 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

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.

↑