Submission Details
| 510(k) Number | K990954 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 1999 |
| Decision Date | June 09, 1999 |
| Days to Decision | 79 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
Cleared
Traditional
ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET
Jun 1999
Decision
79d
Days
Class 1
Risk
About This 510(k) Submission
K990954 is an FDA 510(k) clearance for the ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET, a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on June 9, 1999, 79 days after receiving the submission on March 22, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.
Device Classification
| Product Code | EBW — Controller, Foot, Handpiece And Cord |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 872.4200 |
Manufacturer
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