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510(k) K901994

ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM by Rosofsky & Ross, Inc. — Product Code EFW

K901994 is an FDA 510(k) premarket notification submitted by Rosofsky & Ross, Inc. for the device "ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 31, 1990. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
July 31, 1990
Date Received
May 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Toothbrush, Manual
Device Class
Class I
Regulation Number
872.6855
Review Panel
DE
Submission Type

Other clearances for product code EFW

  • K130186 — DENTEK EASY BRUSH WITH FLUORIDE (July 15, 2013)
  • K121165 — BEAM BRUSH/BEAM APP (June 21, 2012)
  • K102871 — SILVER CARE ANITBACTERIAL TOOTHBRUSH (October 3, 2011)
  • K073224 — ORAL-B SUB-BRAND MANUAL TOOTHBRUSH (February 6, 2008)
  • K021383 — ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL (July 17, 2002)
  • K020776 — MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS (June 3, 2002)
  • K000290 — LAZERSMILE, LAZERWHITE (April 14, 2000)
  • K994144 — TOOTHBRUSH WASH (March 2, 2000)
  • K992435 — BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER (October 15, 1999)
  • K980995 — PLAQ-ATAQ-I (August 20, 1998)

FDA data resources