Atlas FDA

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

Artech Corp. — Predicate Candidate Screening

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

106 daysmedian FDA review time
323 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K911735ARTECH ARDENT IV - TYPE CLYLINDER IMPLANTArtech Corp.1992-03-053230
K895267ARTECH TYPE SS-HA SUBMERGED SCREW IMPLANTArtech Corp.1990-04-102300
K891346ARTECH TYPE SS SUBMERGED SCREW IMPLANTArtech Corp.1989-12-212860
K894160HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPLArtech Corp.1989-09-281060
K894150COUNTERBORE FOR SS SUBMERGED SCREW PLANTArtech Corp.1989-09-271050
K894151IRRIGATED DRILL FOR SS SUBMERGED SCREW PLANTArtech Corp.1989-09-271050
K843217HOLLOW BASKET DENTAL IMPLANTSArtech Corp.1984-10-15610
K843218TPS SCREW DENTAL IMPLANTSArtech Corp.1984-09-27430

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