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510(k) K873605

COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE by Pain Prevention Laboratory, Inc. — Product Code LWM

K873605 is an FDA 510(k) premarket notification submitted by Pain Prevention Laboratory, Inc. for the device "COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code LWM (Device, Electrical Dental Anesthesia), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
September 4, 1987
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)
  • 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