COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS— 510(k) K900799

Name: FDA 510(k) clearance K900799
Creator: U.S. Food and Drug Administration
Published: 1990-05-15

Substantially Equivalent

Comfort Acrylics Co.

FDA 510(k) clearance K900799 for COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS, Substantially Equivalent on 1990-05-15. Applicant: Comfort Acrylics Co.. Device class: 2.

Clearance details

Applicant: Comfort Acrylics Co.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
Advisory panel: Dental
Date received: 1990-02-20
Decision date: 1990-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camas, WA, US

Download summary PDF View on FDA.gov ↗

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K910795 — COMFOR-DENT DENTURE LINER1991-07-11

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

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.