Atlas FDA

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

Imz, GmbH · Predicate Candidate Screening

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

116 daysmedian FDA review time
337 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K963520IMZ TWIN PLUS SCREWImz, GmbH1997-08-123430
K963521IMZ TWIN PLUS - CYLINDERImz, GmbH1997-08-063370
K963522IMZ 2000 INTERLOCK 12/3 - SCREWImz, GmbH1997-03-031810
K963495IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEMImz, GmbH1997-03-031810
K951611IMZ - DENTAL IMPLANT SINGLE TOOTH ATTACHMENTImz, GmbH1995-08-011160
K951609IMZ - DENTAL IMPLANT SURGICAL TRAYImz, GmbH1995-08-011160
K951618IMZ - DENTAL IMPLANT O-RING ATTACHMENTImz, GmbH1995-07-261100
K951612IMZ - DENTAL IMPLANT COMPONENTSImz, GmbH1995-07-261100
K951615IMZ - DENTAL IMPLANT COMPONENTSImz, GmbH1995-07-261100
K951610IMZ - DENTAL IMPLANTImz, GmbH1995-07-261100
K951614IMZ - DENTAL IMPLANTImz, GmbH1995-07-261100
K951617IMZ - DENTAL IMPLANT CASTABLE CSR ATTACHMENTImz, GmbH1995-07-261100

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