RELIEF ACP ORAL CARE GEL— 510(k) K062176

Substantially Equivalent

Discus Dental, Inc.

FDA 510(k) clearance K062176 for RELIEF ACP ORAL CARE GEL, Substantially Equivalent on 2007-01-10. Applicant: Discus Dental, Inc.. Device class: 2.

Clearance details

Applicant: Discus Dental, Inc.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2006-07-31
Decision date: 2007-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K062176

K-number listed on FDA's recall record

Z-0425-2015 — Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kitsClass II·Terminated·Discus Dental LLC·20141024

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062176.

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