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510(k) K942203

OTC DENTURE CLEANSER by Combe, Inc. — Product Code EFT

K942203 is an FDA 510(k) premarket notification submitted by Combe, Inc. for the device "OTC DENTURE CLEANSER". The FDA issued a decision of Substantially Equivalent on August 10, 1994. The device falls under product code EFT (Cleanser, Denture, Over The Counter), a Class I device regulated under 21 CFR 872.3520. Combe, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1994
Date Received
May 5, 1994
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 Combe, Inc.

  • K925259 — CFR MONOGRAPH (January 11, 1993)
  • K863375 — SEA-BOND (September 19, 1986)
  • K780719 — FUNGUS FIGHTER INSOLES (October 10, 1978)
  • K770413 — CUSHIONS, DENTURE ADHESIVE, ALL-DAY (June 24, 1977)
  • K770175 — SEA-BOND ADHEVISE DENTURE CUSHIONS (February 4, 1977)

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)
  • 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)
  • K890043 — DENTCLEAN CONCENTRATED DENTURE CLEANSER (June 7, 1989)

FDA data resources