Atlas FDA

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

Implant Support Systems, Inc. · Predicate Candidate Screening

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

280 daysmedian FDA review time
650 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K933532SELF TAPPING DENTAL IMPLANT SYSTEMImplant Support Systems, Inc.1994-09-214270
K924589RESTORE SELF TAPPING DENTAL IMPLANT SYSTEMImplant Support Systems, Inc.1994-06-226500
K925312HAND INSTRUMENT CALCULUS REMOVALImplant Support Systems, Inc.1994-05-235790
K925313TITANIUM COC ABUTMENT HEADS FOR IMZImplant Support Systems, Inc.1993-07-302820
K925349ONE SYSTEM TAPERED TITANIUM ABUTMENTSImplant Support Systems, Inc.1993-07-272780
K924190ISS O-RING ATTACHMENTImplant Support Systems, Inc.1993-05-272800
K921764DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECISImplant Support Systems, Inc.1992-11-032030
K904605TITANIUM COC ABUTMENT HEADS FOR IMZImplant Support Systems, Inc.1991-01-291110
K895986PRECISION DENTAL ATTACHMENTSImplant Support Systems, Inc.1989-10-18900
K892239DENTAL HAND INSTRUMENTSImplant Support Systems, Inc.1989-05-18840

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