K972569 is an FDA 510(k) clearance for the E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION. This device is classified as a Handpiece, Contra- And Right-angle Attachment, Dental (Class I - General Controls, product code EGS).
Submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on October 8, 1997, 90 days after receiving the submission on July 10, 1997.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K972569 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 1997 |
| Decision Date | October 08, 1997 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EGS — Handpiece, Contra- And Right-angle Attachment, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |