Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nakanishi, Inc. — Predicate Candidate Screening
40 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
188 daysmedian FDA review time
428 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260773 | Varios Combi Pro2 | Nakanishi, Inc. | 2026-03-10 | 1 | 0 |
| K254163 | VarioSurg 4 | Nakanishi, Inc. | 2025-12-23 | 1 | 0 |
| K252662 | UniBur | Nakanishi, Inc. | 2025-09-19 | 28 | 0 |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX S | Nakanishi, Inc. | 2025-09-19 | 109 | 0 |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered | Nakanishi, Inc. | 2024-09-20 | 84 | 0 |
| K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | 2024-06-24 | 269 | 0 |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON- | Nakanishi, Inc. | 2024-06-20 | 267 | 0 |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M20 | Nakanishi, Inc. | 2024-04-25 | 209 | 0 |
| K230888 | Titanium Turbine | Nakanishi, Inc. | 2023-06-02 | 63 | 0 |
| K230106 | General Cutting Straight | Nakanishi, Inc. | 2023-05-24 | 131 | 0 |
| K222518 | FX Contra | Nakanishi, Inc. | 2022-11-17 | 90 | 0 |
| K203791 | Stainless Turbine | Nakanishi, Inc. | 2022-06-21 | 540 | 0 |
| K202120 | P300 Attachment | Nakanishi, Inc. | 2021-10-22 | 449 | 0 |
| K211584 | Oral Surgery Contra | Nakanishi, Inc. | 2021-08-19 | 87 | 0 |
| K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2020-10-27 | 27 | 0 |
| K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | 2019-04-16 | 168 | 0 |
| K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | 2018-06-19 | 179 | 0 |
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | 2017-11-21 | 215 | 8 |
| K163402 | NLZ Motor System | Nakanishi, Inc. | 2017-08-31 | 269 | 0 |
| K163483 | PANA SPRAY Plus | Nakanishi, Inc. | 2017-08-15 | 246 | 0 |
| K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | 2017-05-11 | 184 | 0 |
| K132264 | PRIMADO2 TOTAL SURGICAL SYSTEM | Nakanishi, Inc. | 2013-12-17 | 148 | 0 |
| K131578 | IPROPHY MOBILE | Nakanishi, Inc. | 2013-09-12 | 104 | 0 |
| K113717 | ULTRASONIC SCALER | Nakanishi, Inc. | 2013-03-05 | 442 | 0 |
| K121901 | TI-MAX Z45 | Nakanishi, Inc. | 2013-02-28 | 244 | 0 |
| K113530 | ULTRASONIC SCALER | Nakanishi, Inc. | 2013-01-31 | 428 | 0 |
| K112024 | TI-MAX X450 | Nakanishi, Inc. | 2012-06-20 | 341 | 0 |
| K113655 | TI-MAX X TURBINE | Nakanishi, Inc. | 2012-03-05 | 84 | 0 |
| K110278 | CORDLESS PROSTHODONTIC SCREWDRIVER WITH TORQUE CALIBRATION S | Nakanishi, Inc. | 2012-02-15 | 380 | 0 |
| K112673 | PROPHY-MATE NEO | Nakanishi, Inc. | 2012-02-07 | 146 | 0 |
| K083112 | PRIMADO | Nakanishi, Inc. | 2009-04-29 | 190 | 0 |
| K081811 | CARE3 PLUS | Nakanishi, Inc. | 2009-01-21 | 209 | 0 |
| K080722 | PRIMADO SURGICAL DRILL | Nakanishi, Inc. | 2008-09-17 | 188 | 0 |
| K073678 | VARIOSURG | Nakanishi, Inc. | 2008-07-10 | 195 | 0 |
| K071447 | VARIOS 75 | Nakanishi, Inc. | 2008-04-18 | 330 | 0 |
| K062731 | ULTRASONIC SCALER, VARIOS 560 | Nakanishi, Inc. | 2007-05-01 | 230 | 0 |
| K031421 | ULTRASONIC SCALER, MODELS VARIOS 350 LUX, VARIOS 350 (NO LIG | Nakanishi, Inc. | 2004-03-26 | 326 | 0 |
| K032395 | PROPHY-MATE | Nakanishi, Inc. | 2003-10-17 | 74 | 0 |
| K020327 | SURGIC IV IMPLANT CONTROL UNIT | Nakanishi, Inc. | 2002-04-08 | 67 | 0 |
| K011926 | ELEC-MATE E | Nakanishi, Inc. | 2001-09-11 | 83 | 0 |
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