Device, Electrical Dental Anesthesia
The Electrical Dental Anesthesia Device (product code LWM) is an electronic device used to deliver controlled electrical stimulation to induce local anesthesia in dental procedures, potentially as an alternative to or adjunct with injectable anesthetics. It is currently unclassified (Class U) and has no assigned regulation number or formal medical specialty, though it is reviewed under the Dental (DE) panel. As an unclassified device, it has not been placed into a regulatory class and requires further determination. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- LWM
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K193570 | Dental Pain Eraser | Jan 17, 2020 | Substantially Equivalent | Synapse Dental |
| K192429 | Dental Pain Eraser | Jan 14, 2020 | Substantially Equivalent | Synapse Dental |
| K182947 | Dental Pain Eraser | Mar 26, 2019 | Substantially Equivalent | Synapse Dental, LLC |
| K011001 | TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM | Jun 07, 2001 | Substantially Equivalent | Satelec |
| K935304 | 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 | Mar 16, 1994 | Substantially Equivalent | 3M Company |
| K935085 | 3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS | Jan 26, 1994 | Substantially Equivalent | 3M Company |
| K935082 | 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION | Jan 26, 1994 | Substantially Equivalent | 3M Company |
| K915717 | CEDETA | Nov 23, 1992 | Substantially Equivalent | D-W Intl. |
| K920119 | 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM | May 22, 1992 | Substantially Equivalent | 3M Company |
| K910625 | ULTRACALM | May 15, 1992 | Substantially Equivalent | Sion Technology, Inc. |
| K902948 | COMFORTRON II (TENS) | Dec 17, 1990 | Substantially Equivalent | M. D. Products |
| K900731 | MEDI LISS DENTAL ANALGESIA DEVICE (SBL601) | Dec 17, 1990 | Substantially Equivalent | Medical Consultants Intl. , Ltd. |
| K884586 | COMFORTRON DENTAL ANESTHESIA APPARATUS | Apr 14, 1989 | Substantially Equivalent | M. D. Products |
| K873604 | E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY | Apr 12, 1988 | Substantially Equivalent | Electronic Waveform Laboratory, Inc. |
| K873605 | COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE | Dec 30, 1987 | Substantially Equivalent | Pain Prevention Laboratory, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.