COLLACARE DENTAL— 510(k) K110388

Substantially Equivalent

Innocoll Pharmaceuticals, Ltd.

FDA 510(k) clearance K110388 for COLLACARE DENTAL, Substantially Equivalent on 2011-08-09. Applicant: Innocoll Pharmaceuticals, Ltd..

Clearance details

Applicant: Innocoll Pharmaceuticals, Ltd.
Product code: Code KGN
Advisory panel: Unknown
Date received: 2011-02-10
Decision date: 2011-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Athlone, Co. Westmeath, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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