Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sulzer Dental, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
338 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K014050 | HEX-LOCK TEMPORARY ABUTMENT | Sulzer Dental, Inc. | 2002-11-13 | 338 | 0 |
| K014175 | SULZER DENTAL CERAMIC SYSTEM-HEXLOCK | Sulzer Dental, Inc. | 2002-03-20 | 90 | 0 |
| K014214 | SULZER DENTAL CERAMIC SYSTEM-SPLINE | Sulzer Dental, Inc. | 2002-03-19 | 88 | 0 |
| K013494 | 3.75MM AND 5.0MM SPLINE TWIST IMPLANT | Sulzer Dental, Inc. | 2002-01-18 | 88 | 0 |
| K013227 | SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT | Sulzer Dental, Inc. | 2001-11-19 | 53 | 1 |
| K012055 | 3.25MM SPLINE TWIST IMPLANT | Sulzer Dental, Inc. | 2001-09-06 | 66 | 0 |
| K011245 | ADVENT IMPLANT SYSTEM, SWISS PLUS IMPLANT SYSTEM | Sulzer Dental, Inc. | 2001-06-25 | 63 | 0 |
| K011028 | SCREW-VENT DENTAL IMPLANT SYSTEM | Sulzer Dental, Inc. | 2001-05-21 | 46 | 1 |
| K011038 | TAPER-LOCK DENTAL IMPLANT SYSTEM | Sulzer Dental, Inc. | 2001-05-15 | 40 | 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