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

Planmeca USA, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time

231 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K111361	PLANMED NUANCE EXCEL	Planmeca USA, Inc.	2011-09-23	130
K081699	PLANMECA SOVEREIGN	Planmeca USA, Inc.	2008-08-29	73
K923534	PM2002 PROLINE	Planmeca USA, Inc.	1994-01-31	564
K923533	ADMARK	Planmeca USA, Inc.	1993-03-04	231
K923461	PM2002 PROLINE, PM2002 PROLINE EC	Planmeca USA, Inc.	1992-12-21	160
K923462	DELIGHT	Planmeca USA, Inc.	1992-12-21	160
K904953	PLANMED SOPHIE	Planmeca USA, Inc.	1991-04-18	164
K904947	PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE	Planmeca USA, Inc.	1991-01-30	90
K904948	PM2002 CC AND PM2002 EC	Planmeca USA, Inc.	1991-01-30	90
K864474	DENTAL RADIOGRAPHIC 90, MODEL PM 2002 CC PANORAMIC	Planmeca USA, Inc.	1986-11-26	13
K842359	AUTOMATIC PATIENT CHAIR PM2000 & A	Planmeca USA, Inc.	1984-09-19	89
K842357	PM 2000 DENTAL UNIT	Planmeca USA, Inc.	1984-09-12	82
K842358	ISOLIGHT	Planmeca USA, Inc.	1984-07-31	39

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