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510(k) K873604

E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY by Electronic Waveform Laboratory, Inc. — Product Code LWM

K873604 is an FDA 510(k) premarket notification submitted by Electronic Waveform Laboratory, Inc. for the device "E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY". The FDA issued a decision of Substantially Equivalent on April 12, 1988. The device falls under product code LWM (Device, Electrical Dental Anesthesia), a Class U device. Electronic Waveform Laboratory, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1988
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 by Electronic Waveform Laboratory, Inc.

  • K103738 — H-WAVE (June 1, 2011)
  • K081998 — H-WAVE SPORT (July 9, 2009)
  • K915230 — H WAVE MUSCLE STIMULATOR (May 8, 1992)
  • K862121 — E.W.L. P-TENS/H-WAVE (June 17, 1987)
  • K813601 — E.W.L. P-TENS MODEL(TENS (March 19, 1982)

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)
  • K910625 — ULTRACALM (May 15, 1992)

FDA data resources