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510(k) K771185

PERIODONTIC TOOTHBRUSH, #0126-0190-00 by Hoyt Laboratories — Product Code EFW

K771185 is an FDA 510(k) premarket notification submitted by Hoyt Laboratories for the device "PERIODONTIC TOOTHBRUSH, #0126-0190-00". The FDA issued a decision of Substantially Equivalent on July 15, 1977. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855. Hoyt Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1977
Date Received
June 29, 1977
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 Hoyt Laboratories

  • K820738 — LUSTRALLOY (April 9, 1982)
  • K811154 — HOYT ECONO-TRAY (May 13, 1981)
  • K810830 — HOYT COTTON ROLLS (April 14, 1981)
  • K780834 — PREVI DENT PROPHYLAXIS MINT NDC (June 2, 1978)
  • K771881 — REPLICA BONDING AGENT (November 9, 1977)
  • K771883 — REPLICA ACID-ETCH (October 20, 1977)
  • K771882 — REPLICA DENTAL COMPOSITE-RADIOPAQUE (October 20, 1977)
  • K771880 — REPLICA DENTAL COMPOSIT (October 20, 1977)
  • K771184 — TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 (July 15, 1977)
  • K771183 — TOOTHBRUSH, PEDODONTIC, #0126-0188-00 (July 15, 1977)

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