510(k) K171155 ยท KMW Handpiece, Rotary Bone Cutting
Surgical Angle Handpiece, Surgical Straight Handpiece
| Applicant | Nakanishi, Inc., Kanuma-Shi, JP |
| Decision | Substantially Equivalent, Nov 21, 2017 |
| Received | Apr 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171155
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2018 | Nakanishi Inc. 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 Terminated |
KMW | None listed |
| Oct 24, 2018 | Nakanishi Inc. 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 Terminated |
KMW | None listed |
| Oct 24, 2018 | Nakanishi Inc. 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 Terminated |
KMW | None listed |
| Oct 24, 2018 | Nakanishi Inc. 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 t Terminated |
KMW | None listed |
| Oct 24, 2018 | Nakanishi Inc. 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 Terminated |
KMW | None listed |
| Oct 24, 2018 | Nakanishi Inc. 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 Terminated |
KMW | None listed |
| Oct 24, 2018 | Nakanishi Inc. 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 us Terminated |
KMW | None listed |
| Oct 24, 2018 | Nakanishi Inc. 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 Terminated |
KMW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.