Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Sulzer Calcitek with 9 510(k) clearances. The most recent is a 510(k) clearance dated Jan 19, 2001: SPLINE DENTAL IMPLANT SYSTEM.
| Jan 19, 2001 | SPLINE DENTAL IMPLANT SYSTEMK010073 · DZE | 510(k) clearances |
| Jun 21, 2000 | TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOGK001786 · DZE | 510(k) clearances |
| Jun 16, 1999 | REMOVABLE CUFF ABUTMENTK984536 · DZE | 510(k) clearances |
| Sep 22, 1998 | SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENTK982305 · DZE | 510(k) clearances |
| Jul 30, 1998 | SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANTK981562 · EBF | 510(k) clearances |
| Nov 20, 1997 | VARIABLE PARALLEL PINK973521 · DZE | 510(k) clearances |
| Jun 23, 1997 | EDOSSEOUS DENTAL IMPLANTK970127 · DZE | 510(k) clearances |
| Jun 23, 1997 | SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEMK970752 · DZE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
