SEALAPEX— 510(k) K972369

Substantially Equivalent

Sybron Dental Specialties, Inc.

FDA 510(k) clearance K972369 for SEALAPEX, Substantially Equivalent on 1997-08-15. Applicant: Sybron Dental Specialties, Inc.. Device class: 2.

Clearance details

Applicant: Sybron Dental Specialties, Inc.
Product code: Product code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 1997-06-25
Decision date: 1997-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, 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.