SUPER STRENGTH DENTURE ADHESIVE CREAM— 510(k) K903568

Name: FDA 510(k) clearance K903568
Creator: U.S. Food and Drug Administration
Published: 1990-10-24

Substantially Equivalent

Teledyne Getz

FDA 510(k) clearance K903568 for SUPER STRENGTH DENTURE ADHESIVE CREAM, Substantially Equivalent on 1990-10-24. Applicant: Teledyne Getz. Device class: 1.

Clearance details

Applicant: Teledyne Getz
Product code: Code KOT
Device class: Class 1
Regulation: 21 CFR 872.3490
Advisory panel: Dental
Date received: 1990-08-07
Decision date: 1990-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elk Grove Village, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOT

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K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM1994-12-20
K941365 — MPI DENTURE ADHESIVE FILM SEALS1994-04-22
K895818 — STEADFAST DENTURE ADHESIVE CREAM1990-04-03
K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM1988-11-01
K872225 — SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER1987-06-30

More clearances from Teledyne Getz

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K923674 — DENSPRO COARSE MINT PROPHY PASTE1992-11-05
K923675 — DENSPRO MEDIUM MINT PROPHY PASTE1992-11-05
K901938 — SUPER STRENGTH DENTURE ADHESIVE CREAM1990-06-06
K901239 — TELEDYNE GETZ'S DISPOSABLE PROPHY ANGLE1990-05-15

Adverse events under product code KOT

product code KOT

Death: 5
Injury: 309
Total: 314

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.