K092412 is an FDA 510(k) clearance for the STRONG IMPLANT HANDPIECES. This device is classified as a Handpiece, Belt And/or Gear Driven, Dental (Class I - General Controls, product code EFA).
Submitted by Saeshin Precision Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on September 3, 2009, 28 days after receiving the submission on August 6, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K092412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2009 |
| Decision Date | September 03, 2009 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EFA - Handpiece, Belt And/or Gear Driven, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |