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510(k) K871879

SOFSWAB by Plastic Engineered Products Co. — Product Code EFW

K871879 is an FDA 510(k) premarket notification submitted by Plastic Engineered Products Co. for the device "SOFSWAB". The FDA issued a decision of Substantially Equivalent on July 28, 1987. The device falls under product code EFW (Toothbrush, Manual), a Class I device regulated under 21 CFR 872.6855. Plastic Engineered Products Co. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1987
Date Received
May 14, 1987
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 Plastic Engineered Products Co.

  • K896745 — JAW BLOCKER (December 14, 1989)

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