Home / 510(k) Clearances / K872225

510(k) K872225

SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER by Block Drug Company, Inc. — Product Code KOT

K872225 is an FDA 510(k) premarket notification submitted by Block Drug Company, Inc. for the device "SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER". The FDA issued a decision of Substantially Equivalent on June 30, 1987. The device falls under product code KOT (Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium), a Class I device regulated under 21 CFR 872.3490. Block Drug Company, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1987
Date Received
June 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
Device Class
Class I
Regulation Number
872.3490
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)
  • K862876 — NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM (August 29, 1986)
  • K800831 — PY-CO-PROX TM DENTAL BRUSH (May 8, 1980)
  • K791064 — DUO TWO LAYER DENTURE CLEANSER (October 9, 1979)
  • K780849 — DENTROL LIQUID DENTURE ADHESIVE (July 31, 1978)

Other clearances for product code KOT

  • K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM (December 20, 1994)
  • K941365 — MPI DENTURE ADHESIVE FILM SEALS (April 22, 1994)
  • K903568 — SUPER STRENGTH DENTURE ADHESIVE CREAM (October 24, 1990)
  • K895818 — STEADFAST DENTURE ADHESIVE CREAM (April 3, 1990)
  • K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (November 1, 1988)
  • K854430 — RIGIDENT CREAM (March 4, 1986)
  • K831493 — DENTURE ADHESIVE SEALS (June 30, 1983)

FDA data resources