Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Implant Direct, LLC — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

130 daysmedian FDA review time
272 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090234SPECTRA SYSTEM DENTAL IMPLANTS 2008Implant Direct, LLC2009-05-151055
K081396SWISSPLANT DENTAL IMPLANT SYSTEMImplant Direct, LLC2009-01-142402
K081101SPECTRA-SYSTEM ABUTMENTS 2008Implant Direct, LLC2009-01-142720
K080633SCREWINDIRECT DENTAL IMPLANTSImplant Direct, LLC2008-07-151320
K080713REACTIVE DENTAL IMPLANT SYSTEMImplant Direct, LLC2008-05-16640
K073161REPLUS DENTAL IMPLANTS (HA)Implant Direct, LLC2008-03-071190
K073049SCREWPLUS DENTAL IMPLANTS (HA)Implant Direct, LLC2007-12-13450
K073033LEGACY DENTAL IMPLANTSImplant Direct, LLC2007-12-10450
K061319SPECTRA SYSTEMImplant Direct, LLC2006-09-291411
K060063LEGACY ABUTMENT SYSTEMImplant Direct, LLC2006-05-191300

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