TUFF-TEMP 2.0— 510(k) K120784

Substantially Equivalent

Pulpdent Corporation

FDA 510(k) clearance K120784 for TUFF-TEMP 2.0, Substantially Equivalent on 2012-06-08. Applicant: Pulpdent Corporation. Device class: 2.

Clearance details

Applicant: Pulpdent Corporation
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2012-03-15
Decision date: 2012-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, 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.