510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K954820Substantially Equivalent

Scalex 800

Dentamerica, Industry CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954820 is the FDA 510(k) clearance record for SCALEX 800, a class II device, cleared for Dentamerica on under FDA product code ELC (Scaler, Ultrasonic). FDA records list 4 510(k) clearances for Dentamerica, from to . As of , FDA records show no recalls naming K954820.

Clearance record

Decision date
Received
(90 days to decision)
Product code
ELC Scaler, Ultrasonic
Regulation
21 CFR 872.4850
Device class
Class II
Review panel
Dental
Applicant
Dentamerica P.O. Box 3200, Industry CA
510(k) summary
Statement
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