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510(k) K903568

SUPER STRENGTH DENTURE ADHESIVE CREAM by Teledyne Getz — Product Code KOT

K903568 is an FDA 510(k) premarket notification submitted by Teledyne Getz for the device "SUPER STRENGTH DENTURE ADHESIVE CREAM". The FDA issued a decision of Substantially Equivalent on October 24, 1990. 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. Teledyne Getz has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1990
Date Received
August 7, 1990
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 Teledyne Getz

  • K923674 — DENSPRO COARSE MINT PROPHY PASTE (November 5, 1992)
  • K923675 — DENSPRO MEDIUM MINT PROPHY PASTE (November 5, 1992)
  • K901938 — SUPER STRENGTH DENTURE ADHESIVE CREAM (June 6, 1990)
  • K901239 — TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE (May 15, 1990)

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)
  • K895818 — STEADFAST DENTURE ADHESIVE CREAM (April 3, 1990)
  • K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (November 1, 1988)
  • K872225 — SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER (June 30, 1987)
  • K854430 — RIGIDENT CREAM (March 4, 1986)
  • K831493 — DENTURE ADHESIVE SEALS (June 30, 1983)

FDA data resources