510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K000846Substantially Equivalent

Tkd Scalers

Orasystems, Morris Plains NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000846 is the FDA 510(k) clearance record for TKD SCALERS, a class II device, cleared for Orasystems on under FDA product code ELC (Scaler, Ultrasonic). FDA records list 3 510(k) clearances for Orasystems, from to . As of , FDA records show no recalls naming K000846.

Clearance record

Decision date
Received
(264 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
Orasystems 764 Speedwell Ave., Morris Plains NJ
510(k) summary
Summary
Third party review
No

Clearances, product code ELC

Trailing 12 months
2 clearances under product code ELC in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ELC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260