Surgical Angle Handpiece, Surgical Straight Handpiece— 510(k) K171155

Clearance details

Applicant

Nakanishi, Inc.

Product code

Code KMW

Device class

Class 2

Regulation

21 CFR 872.4120

Advisory panel

Dental

Date received

2017-04-20

Decision date

2017-11-21

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Kanuma-Shi, JP

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Injury

175

Total

175

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0219-2019 — Surgical Handpiece, Model: SGS-E, Order Code: H084, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.Class II·Terminated·Nakanishi Inc.·20180601
• Z-0220-2019 — Surgical Handpiece, Model: SGS-E2G Order Code: H185, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.Class II·Terminated·Nakanishi Inc.·20180601
• Z-0221-2019 — Surgical Handpiece, Model: SGA-E Order Code: H083, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.Class II·Terminated·Nakanishi Inc.·20180601
• Z-0222-2019 — Surgical Handpiece, Model: SGA-E2G Order Code: H184, Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.Class II·Terminated·Nakanishi Inc.·20180601
• Z-0223-2019 — Micro Surgery Handpiece SGS, Model: SGS-ES, Order Code: H264, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.Class II·Terminated·Nakanishi Inc.·20180601
• Z-0224-2019 — Micro Surgery Handpiece SGS, Model: SGS-E2S, Order Code: H266, Manufactured by: Nakanishi Inc The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible..Class II·Terminated·Nakanishi Inc.·20180601
• Z-0225-2019 — Micro Surgery Handpiece SGA, Model SGA-ES, Order Code:H263, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.Class II·Terminated·Nakanishi Inc.·20180601
• Z-0226-2019 — Micro Surgery Handpiece SGA, Model SGA-E2S Order Code: H265, Manufactured by: Nakanishi Inc. The SGS/SGA Surgical Handpieces are intended for surgical use. Typical usage includes dental implant use: drilling and tapping the maxilla and mandible.Class II·Terminated·Nakanishi Inc.·20180601

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171155.