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., part of Zimmer BiometLabelled by claude-sonnet-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 Calcitek, Inc. with 21 510(k) clearances. The most recent is a 510(k) clearance dated Feb 10, 1997: SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM.
| Feb 10, 1997 | SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEMK962576 · DZE | 510(k) clearances |
| Aug 29, 1996 | SPLINE DENTAL IMPLANT SYSTEMSK962106 · DZE | 510(k) clearances |
| Mar 8, 1996 | 5.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMSK955619 · DZE | 510(k) clearances |
| Feb 8, 1996 | CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMSK960021 · DZE | 510(k) clearances |
| Feb 8, 1996 | INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEMK943604 · DZE | 510(k) clearances |
| Nov 15, 1995 | INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEMK946319 · DZE | 510(k) clearances |
| Nov 15, 1995 | INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEMK946345 · DZE | 510(k) clearances |
| Oct 4, 1995 | INTEGRAL VII 3.25MM BIOINTEGRATED DENTAL IMPLANT SYSTEMK946311 · 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
