Submission Details
| 510(k) Number | K990646 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 01, 1999 |
| Decision Date | March 19, 1999 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
Cleared
Traditional
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
Mar 1999
Decision
18d
Days
Class 1
Risk
About This 510(k) Submission
K990646 is an FDA 510(k) clearance for the PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE, a Handpiece, Direct Drive, Ac-powered (Class I — General Controls, product code EKX), submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on March 19, 1999, 18 days after receiving the submission on March 1, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.
Device Classification
| Product Code | EKX — Handpiece, Direct Drive, Ac-powered |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4200 |
Manufacturer
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