KULZER GLAS-IONOMER CEMENT— 510(k) K892453

Substantially Equivalent

Kulzer, Inc.

FDA 510(k) clearance K892453 for KULZER GLAS-IONOMER CEMENT, Substantially Equivalent on 1989-12-04. Applicant: Kulzer, Inc.. Device class: 2.

Clearance details

Applicant: Kulzer, Inc.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 1989-04-10
Decision date: 1989-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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