Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress— 510(k) K153067

Name: FDA 510(k) clearance K153067
Creator: U.S. Food and Drug Administration
Published: 2016-07-27

Substantially Equivalent

Sybron Dental Specialties

FDA 510(k) clearance K153067 for Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress, Substantially Equivalent on 2016-07-27. Applicant: Sybron Dental Specialties. Device class: 2.

Clearance details

Applicant: Sybron Dental Specialties
Product code: Code KIF
Device class: Class 2
Regulation: 21 CFR 872.3820
Advisory panel: Dental
Date received: 2015-10-22
Decision date: 2016-07-27
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.