E-CUBE
Handpiece, Direct Drive, Ac-powered
SAESHIN PRECISION CO., LTD.
The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for E-cube.
Pre-market Notification Details
| Device ID | K111616 |
| 510k Number | K111616 |
| Device Name: | E-CUBE |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | SAESHIN PRECISION CO., LTD. #93-15, PAHO-DONG, DALSEO-GU Daegu, KR 704-220 |
| Contact | Y S Lee |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-06-10 |
| Decision Date | 2011-08-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809260470910 | K111616 | 000 |
| 08809260470903 | K111616 | 000 |
| 08809260470514 | K111616 | 000 |
| 08809260470507 | K111616 | 000 |
| 08809260470491 | K111616 | 000 |
| 08809260470484 | K111616 | 000 |
| 08809260470477 | K111616 | 000 |
Trademark Results [E-CUBE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 E-CUBE 86224124 4846854 Live/Registered |
B+ Equipment 2014-03-18 |
 E-CUBE 79143962 4910633 Live/Registered |
Eisenmann SE 2013-11-06 |
 E-CUBE 79092640 4058236 Live/Registered |
ALPINION MEDICAL SYSTEMS CO., LTD. 2010-10-08 |
 E-CUBE 78153455 not registered Dead/Abandoned |
Encoder Products Company, Inc. 2002-08-12 |
 E-CUBE 76112060 not registered Dead/Abandoned |
Nagase & Co., Ltd. 2000-08-17 |
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