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

Nsk Nakanishi, Inc. · Predicate Candidate Screening

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

79 daysmedian FDA review time
90 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K991701MACH-SIGMA HANDPIECE, ULTRAPUSH, MODELS MACH-SIGMA MU (MINI Nsk Nakanishi, Inc.1999-08-10830
K991021SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITNsk Nakanishi, Inc.1999-06-23860
K990954ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SETNsk Nakanishi, Inc.1999-06-09790
K990682PROPHY-MATE MOTOR HANDPIECE, MODELS PROPHY-MATE (2000 RPM MANsk Nakanishi, Inc.1999-03-24210
K990646PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATENsk Nakanishi, Inc.1999-03-19180
K980162MACH-SIGMA HANDPIECE, ULTRAPUSHNsk Nakanishi, Inc.1998-06-051400
K972924SURGIC II IMPLANT CONTROL UNITNsk Nakanishi, Inc.1997-10-30830
K972569E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INNsk Nakanishi, Inc.1997-10-08900
K971774NSK PUSH-BUTTON MIDWEST REPLACEMENT TURBINE:FOR QUIETAIR ANDNsk Nakanishi, Inc.1997-06-20380
K970953E-TYPE SPEED REDUCER CONTRA ANGLENsk Nakanishi, Inc.1997-04-15290
K962542AIR MOTOR HANDPIECE TN-102Nsk Nakanishi, Inc.1996-09-24880
K962540E-TYPE CONTRA ANGLE NAC-ENsk Nakanishi, Inc.1996-09-12760
K962543ALPHA AIR HANDPIECE, ULTRA-PUSH, AL-SU, AL-MU, AL-TUNsk Nakanishi, Inc.1996-09-11750

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