The following data is part of a premarket notification filed by Saeshin Precision Co., Ltd. with the FDA for Strong Implant Handpieces.
| Device ID | K092412 |
| 510k Number | K092412 |
| Device Name: | STRONG IMPLANT HANDPIECES |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | SAESHIN PRECISION CO., LTD. 1007, BYUCKSAN 2CHA 481-10,GASAN-DONG,GEUMCHEON-GU Seoul, KR |
| Contact | Seong Nam Kim |
| Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-08-06 |
| Decision Date | 2009-09-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809260470453 | K092412 | 000 |
| 08809260470446 | K092412 | 000 |
| 08809260470439 | K092412 | 000 |
| 08809260470422 | K092412 | 000 |
| 08809260470415 | K092412 | 000 |
| 08809260470408 | K092412 | 000 |
| 08809260470392 | K092412 | 000 |
| 08809260470385 | K092412 | 000 |