Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

The Implant Center of the Palm Beaches · Predicate Candidate Screening

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

69 daysmedian FDA review time
120 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K974280ABUTMENT - COMPLETEThe Implant Center of the Palm Beaches1998-02-201070
K960111KIS MT4The Implant Center of the Palm Beaches1996-03-27760
K960110KIS MT3The Implant Center of the Palm Beaches1996-03-20690
K960112KIS MT5The Implant Center of the Palm Beaches1996-03-15640
K955048KIS MED THREAD IMPLANT & PROSTHESIS SYSTEMThe Implant Center of the Palm Beaches1996-01-11690
K953558KIS II LG HEX SCREW & CYLINDER IMPLANTSThe Implant Center of the Palm Beaches1995-12-191540
K953234SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-B3The Implant Center of the Palm Beaches1995-11-081200
K954539LG HEX PROSTHETICSThe Implant Center of the Palm Beaches1995-10-30520
K953237PROSTHETICS & INSTRUMENTATION A. PROSTHETIC ABUTMENTS 4, 5, The Implant Center of the Palm Beaches1995-09-15660
K953235SCREW IMPLANTS, GRADE 3; UNCOATED, HA, TP-K3The Implant Center of the Palm Beaches1995-09-13640
K953236CYLINDER IMPLANTS HA, TP, GRADE 3The Implant Center of the Palm Beaches1995-09-13640
K950893KIS-V PRE-ANGULATED AND WIDE BODY ABUTMENTSThe Implant Center of the Palm Beaches1995-05-05660

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