Barrier Sleeves— 510(k) K191448

Substantially Equivalent

Ivoclar Vivadent, AG

FDA 510(k) clearance K191448 for Barrier Sleeves, Substantially Equivalent on 2019-10-08. Applicant: Ivoclar Vivadent, AG.

Clearance details

Applicant: Ivoclar Vivadent, AG
Product code: Code PEM
Advisory panel: General, Plastic Surgery
Date received: 2019-05-31
Decision date: 2019-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaan, LI

Download summary PDF View on FDA.gov ↗

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