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510(k) K851183

PEPSODENT DENTURE CLEANSER PDP FORMULA by Lever Brothers Company, Inc. — Product Code EFT

K851183 is an FDA 510(k) premarket notification submitted by Lever Brothers Company, Inc. for the device "PEPSODENT DENTURE CLEANSER PDP FORMULA". The FDA issued a decision of Substantially Equivalent on April 29, 1985. The device falls under product code EFT (Cleanser, Denture, Over The Counter), a Class I device regulated under 21 CFR 872.3520. Lever Brothers Company, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1985
Date Received
March 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Denture, Over The Counter
Device Class
Class I
Regulation Number
872.3520
Review Panel
DE
Submission Type

Other clearances by Lever Brothers Company, Inc.

  • K850610 — PEPSODENT DENTURE ADHESIVE CREAM (May 15, 1985)
  • K851182 — PEPSODENT DENTURE CLEANSER-WESTONE FORMULA (April 29, 1985)
  • K781018 — DX TOOTHBRUSH (June 30, 1978)

Other clearances for product code EFT

  • K080631 — CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER (May 23, 2008)
  • K051342 — MEDICAL INTERPOROUS (June 2, 2006)
  • K000996 — TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND (June 16, 2000)
  • K942203 — OTC DENTURE CLEANSER (August 10, 1994)
  • K930337 — PROFAST(R)-DENTURE CLEANSER (September 7, 1993)
  • K914257 — DENTURE PRODUCT X (January 13, 1993)
  • K925259 — CFR MONOGRAPH (January 11, 1993)
  • K902838 — DENTURE DYNAMIC'S DENTURE MAGIC (September 6, 1990)
  • K903686 — ARGILITE 4 GOLD ALLOY FOR PORCELAIN (August 29, 1990)
  • K895345 — ORAD TOOTHBRUSH CLEANER (March 7, 1990)

FDA data resources