STEADFAST DENTURE ADHESIVE CREAM— 510(k) K895818

Name: FDA 510(k) clearance K895818
Creator: U.S. Food and Drug Administration
Published: 1990-04-03

Substantially Equivalent

Stiefel Research Institute, Inc.

FDA 510(k) clearance K895818 for STEADFAST DENTURE ADHESIVE CREAM, Substantially Equivalent on 1990-04-03. Applicant: Stiefel Research Institute, Inc.. Device class: 1.

Clearance details

Applicant: Stiefel Research Institute, Inc.
Product code: Code KOT
Device class: Class 1
Regulation: 21 CFR 872.3490
Advisory panel: Dental
Date received: 1989-09-29
Decision date: 1990-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oakhill, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOT

view all

K945462 — SUPER POLI-GRIP DENTURE ADHESIVE CREAM1994-12-20
K941365 — MPI DENTURE ADHESIVE FILM SEALS1994-04-22
K903568 — SUPER STRENGTH DENTURE ADHESIVE CREAM1990-10-24
K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM1988-11-01
K872225 — SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER1987-06-30

More clearances from Stiefel Research Institute, Inc.

view all

K914591 — L.C.S. 2000 SYSTEM1992-01-14
K910216 — STEADFAST DENTURE ADHESIVE POWDER1991-03-29
K895817 — HERMAL WOUND CARE KIT1990-01-19
K896724 — CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.1990-01-09
K893996 — CUSIS ULTRASOUND SKIN IMAGING SYSTEM1989-09-21

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.