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510(k) K182947

Dental Pain Eraser by Synapse Dental, LLC — Product Code LWM

K182947 is an FDA 510(k) premarket notification submitted by Synapse Dental, LLC for the device "Dental Pain Eraser". The FDA issued a decision of Substantially Equivalent on March 26, 2019. The device falls under product code LWM (Device, Electrical Dental Anesthesia), a Class U device. Synapse Dental, LLC has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2019
Date Received
October 23, 2018
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 Synapse Dental, LLC

  • K193570 — Dental Pain Eraser (January 17, 2020)
  • K192429 — Dental Pain Eraser (January 14, 2020)

Other clearances for product code LWM

  • K193570 — Dental Pain Eraser (January 17, 2020)
  • K192429 — Dental Pain Eraser (January 14, 2020)
  • 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)
  • K900731 — MEDI LISS DENTAL ANALGESIA DEVICE (SBL601) (December 17, 1990)

FDA data resources