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
K910625Substantially Equivalent

Ultracalm

Sion Technology, Inc., Aurora CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910625 is the FDA 510(k) clearance record for ULTRACALM, cleared for Sion Technology, Inc. on under FDA product code LWM (Device, Electrical Dental Anesthesia). FDA records list one 510(k) clearance for Sion Technology, Inc. As of , FDA records show no recalls naming K910625.

Clearance record

Decision date
Received
(458 days to decision)
Product code
LWM Device, Electrical Dental Anesthesia
Device class
Unclassified
Review panel
Unknown
Applicant
Sion Technology, Inc. 1390 S. Potomac St. -, Aurora CO
Third party review
No

Clearances, product code LWM

Trailing 12 months

FDA records hold no clearances under product code LWM in the trailing twelve months.

FDA records show no clearances under product code LWM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260