Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sulzer Calcitek, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
177 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010073 | SPLINE DENTAL IMPLANT SYSTEM | Sulzer Calcitek, Inc. | 2001-01-19 | 10 | 0 |
| K001786 | TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANAL | Sulzer Calcitek, Inc. | 2000-06-21 | 8 | 0 |
| K984536 | REMOVABLE CUFF ABUTMENT | Sulzer Calcitek, Inc. | 1999-06-16 | 177 | 0 |
| K982305 | SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT | Sulzer Calcitek, Inc. | 1998-09-22 | 83 | 0 |
| K981562 | SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT | Sulzer Calcitek, Inc. | 1998-07-30 | 90 | 0 |
| K973521 | VARIABLE PARALLEL PIN | Sulzer Calcitek, Inc. | 1997-11-20 | 64 | 0 |
| K970127 | EDOSSEOUS DENTAL IMPLANT | Sulzer Calcitek, Inc. | 1997-06-23 | 160 | 0 |
| K970752 | SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM | Sulzer Calcitek, Inc. | 1997-06-23 | 112 | 0 |
| K964768 | THREADLOC DENTAL IMPLANT SYSTEMS | Sulzer Calcitek, Inc. | 1997-02-25 | 90 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda