GLUMA COMFORT BOND + DESENSITIZER— 510(k) K992292

Name: FDA 510(k) clearance K992292
Creator: U.S. Food and Drug Administration
Published: 1999-10-01

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K992292 for GLUMA COMFORT BOND + DESENSITIZER, Substantially Equivalent on 1999-10-01. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 1999-07-07
Decision date: 1999-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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