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510(k) K902948

COMFORTRON II (TENS) by M. D. Products — Product Code LWM

K902948 is an FDA 510(k) premarket notification submitted by M. D. Products for the device "COMFORTRON II (TENS)". The FDA issued a decision of Substantially Equivalent on December 17, 1990. The device falls under product code LWM (Device, Electrical Dental Anesthesia), a Class U device. M. D. Products has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1990
Date Received
July 5, 1990
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 by M. D. Products

  • K884586 — COMFORTRON DENTAL ANESTHESIA APPARATUS (April 14, 1989)
  • K871227 — LES RAD FILTER (June 29, 1987)

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)
  • K935085 — 3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS (January 26, 1994)
  • K935082 — 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION (January 26, 1994)
  • K915717 — CEDETA (November 23, 1992)
  • K920119 — 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM (May 22, 1992)
  • K910625 — ULTRACALM (May 15, 1992)

FDA data resources