SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT— 510(k) K981562

Name: FDA 510(k) clearance K981562
Creator: U.S. Food and Drug Administration
Published: 1998-07-30

Substantially Equivalent

Sulzer Calcitek, Inc.

FDA 510(k) clearance K981562 for SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT, Substantially Equivalent on 1998-07-30. Applicant: Sulzer Calcitek, Inc.. Device class: 2.

Clearance details

Applicant: Sulzer Calcitek, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1998-05-01
Decision date: 1998-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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