Cleared Traditional

K991021 - SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL

K991021 is an FDA 510(k) clearance for SONIC SCALER WITH FIBER OPTIC, manufactured by Nsk Nakanishi, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K991021 · Nsk Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
86d
Days
Class 2
Risk

K991021 is an FDA 510(k) clearance for the SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC,.... Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Nsk Nakanishi, Inc. (Tochigi-Ken, JP). The FDA issued a Cleared decision on June 23, 1999 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nsk Nakanishi, Inc. devices

FDA 510(k) Submission Details - K991021

510(k) Number K991021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 118
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K991021.
DELSONIC 2000
K990546 · Sds Dental, Inc. · Nov 1999
VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2
K991239 · Micron Corp. · Oct 1999
EMS SURFACE MOUNT SCALER
K991874 · (Ems Sa) Electro Medical Systems · Jul 1999
POWER PLUS 25K MODEL, S1000, POWER PLUS 30K MODEL,S1001
K983029 · Tpc Advanced Technology, Inc. · Jan 1999
BIOSONIC ULTRASONIC SCALER SYSTEM
K983727 · Coltene/Whaledent, Inc. · Jan 1999
PIEZO TRONIC
K982793 · Advanced Medical Devices, Inc. · Oct 1998