510(k) K902948
- Device
- Comfortron Ii (tens)
- Applicant
- M. D. PRODUCTS
- 510(k) number
- K902948
- Product code
- LWM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-12-17
- Date received
- 1990-07-05
- Classification name
- Device, Electrical Dental Anesthesia
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DREYFUS, DDS
- Address
- 2137 SE Fort King Ocala FL US 32671 32671
FDA Registration Numbers#
- 2023152
- 3015528161
- 8044015
- 3006258094
- 3017463707
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LWM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193570 | Dental Pain Eraser | Synapse Dental | 2020-01-17 |
| K192429 | Dental Pain Eraser | Synapse Dental | 2020-01-14 |
| K182947 | Dental Pain Eraser | Synapse Dental, LLC | 2019-03-26 |
| K011001 | TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM | Satelec | 2001-06-07 |
| K935304 | 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 | 3M Company | 1994-03-16 |
| K935082 | 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION | 3M Company | 1994-01-26 |
| K935085 | 3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS | 3M Company | 1994-01-26 |
| K915717 | CEDETA | D-W Intl. | 1992-11-23 |
| K920119 | 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM | 3M Company | 1992-05-22 |
| K910625 | ULTRACALM | Sion Technology, Inc. | 1992-05-15 |
| K900731 | MEDI LISS DENTAL ANALGESIA DEVICE (SBL601) | Medical Consultants Intl. , Ltd. | 1990-12-17 |
| K884586 | COMFORTRON DENTAL ANESTHESIA APPARATUS | M. D. Products | 1989-04-14 |
| K873604 | E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY | Electronic Waveform Laboratory, Inc. | 1988-04-12 |
| K873605 | COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE | Pain Prevention Laboratory, Inc. | 1987-12-30 |