Medical Device Manufacturer · US , Carlsbad , CA

Sulzer Calcitek, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 1997

Recent clearances: REMOVABLE CUFF ABUTMENT, SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT, SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sulzer Calcitek, Inc. Dental ✕

9 devices

1-9 of 9

Cleared Jan 19, 2001

SPLINE DENTAL IMPLANT SYSTEM

Cleared Jun 21, 2000

TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG

Cleared Jun 16, 1999

REMOVABLE CUFF ABUTMENT

Cleared Sep 22, 1998

SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT

Cleared Jul 30, 1998

SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT

Cleared Nov 20, 1997

VARIABLE PARALLEL PIN

Cleared Jun 23, 1997

EDOSSEOUS DENTAL IMPLANT

Cleared Jun 23, 1997

SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM

Cleared Feb 25, 1997

THREADLOC DENTAL IMPLANT SYSTEMS

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 06, 2026