DENTURE ADHESIVE SEALS— 510(k) K831493

Name: FDA 510(k) clearance K831493
Creator: U.S. Food and Drug Administration
Published: 1983-06-30

Substantially Equivalent

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K831493 for DENTURE ADHESIVE SEALS, Substantially Equivalent on 1983-06-30. Applicant: Johnson & Johnson Professionals, Inc.. Device class: 1.

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code KOT
Device class: Class 1
Regulation: 21 CFR 872.3490
Advisory panel: Dental
Date received: 1983-05-10
Decision date: 1983-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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K941365 — MPI DENTURE ADHESIVE FILM SEALS1994-04-22
K903568 — SUPER STRENGTH DENTURE ADHESIVE CREAM1990-10-24
K895818 — STEADFAST DENTURE ADHESIVE CREAM1990-04-03
K884357 — PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM1988-11-01

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K982379 — SUNDT SLIM-LINE ANEURYSM CLIP APPLIER1998-12-18
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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.