DENTALON PLUS MODIFICATION— 510(k) K934283

Name: FDA 510(k) clearance K934283
Creator: U.S. Food and Drug Administration
Published: 1993-12-10

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K934283 for DENTALON PLUS MODIFICATION, Substantially Equivalent on 1993-12-10. Applicant: Heraeus Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 1993-08-31
Decision date: 1993-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.