MULTIPLE RESIN TOOTH BONDING AGENT— 510(k) K052501

Name: FDA 510(k) clearance K052501
Creator: U.S. Food and Drug Administration
Published: 2005-10-21

Substantially Equivalent

Cosmedent, Inc.

FDA 510(k) clearance K052501 for MULTIPLE RESIN TOOTH BONDING AGENT, Substantially Equivalent on 2005-10-21. Applicant: Cosmedent, Inc.. Device class: 2.

Clearance details

Applicant: Cosmedent, Inc.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2005-09-13
Decision date: 2005-10-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K052501

K-number listed on FDA's recall record

Z-0741-2018 — Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.Class II·Terminated·Cosmedent, Inc.·20170928

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052501.

Data sourced from openFDA. This site is unofficial and independent of the FDA.