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510(k) K193570

Dental Pain Eraser by Synapse Dental — Product Code LWM

K193570 is an FDA 510(k) premarket notification submitted by Synapse Dental for the device "Dental Pain Eraser". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code LWM (Device, Electrical Dental Anesthesia), a Class U device. Synapse Dental has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2020
Date Received
December 23, 2019
Clearance Type
Special
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 Synapse Dental

  • K192429 — Dental Pain Eraser (January 14, 2020)
  • K182947 — Dental Pain Eraser (March 26, 2019)

Other clearances for product code LWM

  • 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)
  • K910625 — ULTRACALM (May 15, 1992)
  • K902948 — COMFORTRON II (TENS) (December 17, 1990)

FDA data resources