VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS— 510(k) K981954

Name: FDA 510(k) clearance K981954
Creator: U.S. Food and Drug Administration
Published: 1999-01-25

Substantially Equivalent

Healthline Implants, Inc.

FDA 510(k) clearance K981954 for VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS, Substantially Equivalent on 1999-01-25. Applicant: Healthline Implants, Inc.. Device class: 2.

Clearance details

Applicant: Healthline Implants, Inc.
Product code: Code NRQ
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 1998-06-04
Decision date: 1999-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marion, OH, US

Download summary PDF View on FDA.gov ↗

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