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510(k) K791064

DUO TWO LAYER DENTURE CLEANSER by Block Drug Company, Inc. — Product Code EFT

K791064 is an FDA 510(k) premarket notification submitted by Block Drug Company, Inc. for the device "DUO TWO LAYER DENTURE CLEANSER". The FDA issued a decision of Substantially Equivalent on October 9, 1979. The device falls under product code EFT (Cleanser, Denture, Over The Counter), a Class I device regulated under 21 CFR 872.3520. Block Drug Company, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1979
Date Received
June 11, 1979
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 Block Drug Company, Inc.

  • K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM (December 20, 1994)
  • K935925 — VISION PROPHY PASTE WITH FLUORIDE (January 26, 1994)
  • K933893 — VISION PROPHY PASTE WITHOUT FLUORIDE (November 16, 1993)
  • K884533 — SENSODYNE SEALANT DENTIN CONDITIONING SYSTEM (April 12, 1989)
  • K881974 — PROFICIENT(TM) PROPHYLAXIS ANGLE (July 25, 1988)
  • K872225 — SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER (June 30, 1987)
  • K862876 — NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM (August 29, 1986)
  • K800831 — PY-CO-PROX TM DENTAL BRUSH (May 8, 1980)
  • K780849 — DENTROL LIQUID DENTURE ADHESIVE (July 31, 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