SEALEX EXTRA ROOT CANAL SEALER— 510(k) K962885

Substantially Equivalent

Baladent

FDA 510(k) clearance K962885 for SEALEX EXTRA ROOT CANAL SEALER, Substantially Equivalent on 1996-08-30. Applicant: Baladent. Device class: 2.

Clearance details

Applicant: Baladent
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 1996-07-24
Decision date: 1996-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, 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.