Submission Details
| 510(k) Number | K991021 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 29, 1999 |
| Decision Date | June 23, 1999 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
Cleared
Traditional
SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL
Jun 1999
Decision
86d
Days
Class 2
Risk
About This 510(k) Submission
K991021 is an FDA 510(k) clearance for the SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL, a Scaler, Ultrasonic (Class II — Special Controls, product code ELC), submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on June 23, 1999, 86 days after receiving the submission on March 29, 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 |
Manufacturer
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