Submission Details
| 510(k) Number | K991874 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 02, 1999 |
| Decision Date | July 30, 1999 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
K991874 - EMS SURFACE MOUNT SCALER
(FDA 510(k) Clearance)
Jul 1999
Decision
58d
Days
Class 2
Risk
K991874 is an FDA 510(k) clearance for the EMS SURFACE MOUNT SCALER, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by (Ems Sa) Electro Medical Systems (North Attleboro, US). The FDA issued a Cleared decision on July 30, 1999, 58 days after receiving the submission on June 2, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.4850.
Device Classification
| Product Code | ELC — Scaler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4850 |
Similar Devices — ELC Scaler, Ultrasonic
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