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

Implant Center of the Palm Beaches · Predicate Candidate Screening

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

130 daysmedian FDA review time
198 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952985WIDE SCREWS TP-5B. PROS G5, TOOLS G5 OR 17-4 SSImplant Center of the Palm Beaches1995-10-311300
K952991WIDE SCREW HA-5B, CYL-HA-5Implant Center of the Palm Beaches1995-10-311300
K952992PROSTHETICS 4MMImplant Center of the Palm Beaches1995-10-311300
K952994TP-4 WIDE CYLINDER IMPLANTSImplant Center of the Palm Beaches1995-10-311300
K952996HA/TP COATED CYLINDER IMPLANT 3.3,4.0Implant Center of the Palm Beaches1995-10-311300
K952997PRE ANGULATED PROSTH: 15 DEG ANGLED, 25,& 25 CONE ANGLEDImplant Center of the Palm Beaches1995-10-311300
K952998TP SCREW IMPLANT 3.75, 4.0-B5Implant Center of the Palm Beaches1995-10-311300
K952999UNCOATED SCREW IMPLANT 3.75, 4.0-B5Implant Center of the Palm Beaches1995-10-311300
K953000WIDE SYSTEM SCREW B5 UNCOATED 5MM, 6MMImplant Center of the Palm Beaches1995-10-311300
K953001TP-4K SCREW IMPLANT 3.3, 3.75, 4.0Implant Center of the Palm Beaches1995-10-311300
K953280HA, TP CYLINDER, UNIHOLEImplant Center of the Palm Beaches1995-09-15640
K953281HA, TP CYLINDER OVALImplant Center of the Palm Beaches1995-09-15640
K953139KIS-- FOUR HOLE CYLINDERImplant Center of the Palm Beaches1995-09-13690
K952988WIDE SCREWS TP-4K, PROS-G4, TOOLS G4 OR 17-4 SSImplant Center of the Palm Beaches1995-07-26330
K952989WIDE STR-TP-4K, PROS STR, CLY-STR-TP 4Implant Center of the Palm Beaches1995-07-26330
K951606KIS-II IMPLANT FIXTURESImplant Center of the Palm Beaches1995-07-141060
K944725KIS-II STR FIXTURESImplant Center of the Palm Beaches1995-04-262120
K943971KIS-II IMPLANT FIXTURESImplant Center of the Palm Beaches1995-03-011980
K943984KIS-II NON-ANGULATED ABUTMENTSImplant Center of the Palm Beaches1995-03-011970
K944356KIS-II IMPLANT SYSTEM/DRILLSImplant Center of the Palm Beaches1994-12-051110

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