PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE— 510(k) K014133

Name: FDA 510(k) clearance K014133
Creator: U.S. Food and Drug Administration
Published: 2002-03-14

Substantially Equivalent

Pulpdent Corp.

FDA 510(k) clearance K014133 for PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE, Substantially Equivalent on 2002-03-14. Applicant: Pulpdent Corp.. Device class: 2.

Clearance details

Applicant: Pulpdent Corp.
Product code: Code DYH
Device class: Class 2
Regulation: 21 CFR 872.3750
Advisory panel: Dental
Date received: 2001-12-17
Decision date: 2002-03-14
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.