Manufacturer registered with FDA
Saeshin Precision Co., Ltd.
Daegu, South Korea. Lists 9 dental device types with FDA across 1 registered establishment, and holds 16 510(k) clearances as applicant.
- Device types listed
- 9
- Brands and models
- 28
- 510(k) clearances
- 162009–2026
- Markets registered in
- 9211 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Saeshin Precision Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Saeshin Precision Co., Ltd. | 16 clearances | 2009–2026 | Below |
| European Union | EUDAMED | Manufacturer | SAESHIN PRECISION CO.,LTD. | 158 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SAESHIN PRECISION CO.,LTD | 19 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SAESHIN PRECISION CO., LTD. | 15 | 2010–2026 | Pure Global AI |
| China | NMPA | Registration holder | 世新精密有限公司SAESHIN PRECISION CO., LTD.世新精密有限公司SAESHIN PRECISION CO.,LTD. · 世新精密有限公司Saeshin Precision Co., Ltd · +1 | 5 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Saeshin Precision Co Ltd | 4 | 2015–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Saeshin Precision CO., LTDSaeshin Precision Co., Ltd. · Saeshin precision co. | 4 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Saeshin Precision Co., Ltd | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SAESHIN PRECISION CO., LTD. | 3 | 2020–2020 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Saeshin Precision Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | ACL(B)-61I, ACL(B)-62I, ACL(B)-63I, ACL(B)-65I, ACL(B)-04CAHP-85-SSDENTIS DIP20MEARA; MEAHPStrong Dental HandpiecesTRAUS CRB46LNTRAUS CRB46NNTraus SIP20 | 2010 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | AHP-85-SSDENTIS DIP20Harpoon 1Motor Handpiece and Control Unit (SDI10)OsseoFuseSDI10Traus SIP20X-CUBE | 2009 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | PIEZOARTTraus SUS20 | 2015 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | E-CUBE | 2011 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Maker | STRONG IMPLANT HANDPIECES | 2009 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | TRAUS high-speed air turbine Handpieces | 2023 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | DB-001DB-003DB-005 | 2017 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | — | 2018 |
| Water-Powered HandpieceEKY · Class 1 | — | Maker | BIODENT SIP10Maxima Elite iMaxima Elite iLTRAUS SIP 10 | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Saeshin Precision Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Jan 2026 | K251407 | Motor Handpiece and Control Unit (SDI10) | EBW Handpiece and Cord Foot Controller |
| 22 Feb 2023 | K221741 | TRAUS Air Dental Handpiece | EFB Dental Air-Powered Handpiece |
| 24 Jun 2022 | K212043 | TRAUS ENDO | EKX Ac-Powered Direct Drive Handpiece |
| 11 Feb 2021 | K201292 | TRAUS SIP20 | EBW Handpiece and Cord Foot Controller |
| 13 Jul 2020 | K192561 | TRAUS SUS20 | DZI Powered Bone Drill |
| 26 Nov 2019 | K182892 | TRAUS Dental Handpieces | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 31 Jan 2019 | K181129 | STRONG Dental Handpieces | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 5 Jan 2018 | K171436 | STRONG Dental Handpieces | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 1 Sep 2015 | K151171 | TRAUS SUS10 | DZI Powered Bone Drill |
| 31 Jul 2015 | K143418 | STRONG Dental Handpieces | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 29 Jun 2015 | K143411 | TRAUS ENDO | EKX Ac-Powered Direct Drive Handpiece |
| 18 Dec 2012 | K123695 | TRAUS SIP10 | EKY Water-Powered Handpiece |
| 19 Aug 2011 | K111616 | E-CUBE | EKX Ac-Powered Direct Drive Handpiece |
| 4 Feb 2010 | K100192 | STRONG DENTAL HANDPIECES | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 21 Sep 2009 | K092758 | X-CUBE | EBW Handpiece and Cord Foot Controller |
| 3 Sep 2009 | K092412 | STRONG IMPLANT HANDPIECES | EFA Dental Belt and/or Gear Driven Handpiece |
Some of these clearances are listed with FDA today by another company: DIO Corporation (2), Aseptico, Inc. (1), Pac-Dent Inc. (1), ADIN DENTAL IMPLANT SYSTEMS Ltd (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SAESHIN PRECISION CO., LTD.FDA reg. 3007958831 | Daegu, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10030579). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.