The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Strong Dental Handpieces.
| Device ID | K100192 |
| 510k Number | K100192 |
| Device Name: | STRONG DENTAL HANDPIECES |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| 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 | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-01-22 |
| Decision Date | 2010-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809260470347 | K100192 | 000 |
| 08809260470330 | K100192 | 000 |
| 08809260470323 | K100192 | 000 |
| 08809260470316 | K100192 | 000 |
| 08809260471214 | K100192 | 000 |
| 08809260471191 | K100192 | 000 |