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510(k) K955530

RANIR HI-TECHNOLOGY DENTAL FLOSS by Ranir/Dcp Corp. — Product Code EFW

K955530 is an FDA 510(k) premarket notification submitted by Ranir/Dcp Corp. for the device "RANIR HI-TECHNOLOGY DENTAL FLOSS". The FDA issued a decision of Substantially Equivalent on December 28, 1995. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855. Ranir/Dcp Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1995
Date Received
December 4, 1995
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 by Ranir/Dcp Corp.

  • K942690 — RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K942689 — RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (April 27, 1995)
  • K935906 — RANIR PLAX RX (September 2, 1994)
  • K935522 — RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE (January 26, 1994)
  • K924739 — THE DENTIST'S TOOTH POLISHER (November 24, 1992)

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