510(k) K991021

SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL by Nsk Nakanishi, Inc. — Product Code ELC

K991021 is an FDA 510(k) premarket notification submitted by Nsk Nakanishi, Inc. for the device "SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL". The FDA issued a decision of Substantially Equivalent on June 23, 1999. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Nsk Nakanishi, Inc. has at least 10 other 510(k) clearances on record.