Home / 510(k) Clearances / K910625

510(k) K910625

ULTRACALM by Sion Technology, Inc. — Product Code LWM

K910625 is an FDA 510(k) premarket notification submitted by Sion Technology, Inc. for the device "ULTRACALM". The FDA issued a decision of Substantially Equivalent on May 15, 1992. The device falls under product code LWM (Device, Electrical Dental Anesthesia), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1992
Date Received
February 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Electrical Dental Anesthesia
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances for product code LWM

  • K193570 — Dental Pain Eraser (January 17, 2020)
  • K192429 — Dental Pain Eraser (January 14, 2020)
  • K182947 — Dental Pain Eraser (March 26, 2019)
  • K011001 — TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM (June 7, 2001)
  • K935304 — 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 (March 16, 1994)
  • K935082 — 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION (January 26, 1994)
  • K935085 — 3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS (January 26, 1994)
  • K915717 — CEDETA (November 23, 1992)
  • K920119 — 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM (May 22, 1992)
  • K900731 — MEDI LISS DENTAL ANALGESIA DEVICE (SBL601) (December 17, 1990)

FDA data resources