QUANTEC-E IRRIGATION SYSTEM— 510(k) K991035

Name: FDA 510(k) clearance K991035
Creator: U.S. Food and Drug Administration
Published: 1999-06-24

Substantially Equivalent

Sybron Dental Specialties, Inc.

FDA 510(k) clearance K991035 for QUANTEC-E IRRIGATION SYSTEM, Substantially Equivalent on 1999-06-24. Applicant: Sybron Dental Specialties, Inc.. Device class: 1.

Clearance details

Applicant: Sybron Dental Specialties, Inc.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1999-03-29
Decision date: 1999-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

Download summary PDF View on FDA.gov ↗

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