PROTEC CEM.— 510(k) K980922

Substantially Equivalent

Ivoclar North America, Inc.

FDA 510(k) clearance K980922 for PROTEC CEM., Substantially Equivalent on 1998-04-30. Applicant: Ivoclar North America, Inc.. Device class: 2.

Clearance details

Applicant
Ivoclar North America, Inc.
Product code
Code EMA
Device class
Class 2
Regulation
21 CFR 872.3275
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Amherst, NY, US
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