3M Dental Electrononic Anesthesia (DEA0 System 8670 Additional Applications
FDA 510(k) K935085 · 3M Company
510(k) numberK935085
Submission
- Device name
- 3M Dental Electrononic Anesthesia (DEA0 System 8670 Additional Applications
- Applicant
- 3M Company
St. Paul, MN, US - Received
- October 22, 1993
- Decision date
- January 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LWM – Device, Electrical Dental Anesthesia
- Device class
- Unclassified
Other 510(k)s with product code LWM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K193570 | Dental Pain EraserLWM · Special | Synapse Dental | 01/17/2020SE |
| K192429 | Dental Pain EraserLWM · Traditional | Synapse Dental | 01/14/2020SE |
| K182947 | Dental Pain EraserLWM · Traditional | Synapse Dental, LLC | 03/26/2019SE |
| K011001 | Team-Up TM Dental Electronic Anesthesia SystemLWM · Traditional | Satelec | 06/07/2001SE |
| K935304 | 3M Dental Electronic Anesthesia (Dea) System 8670LWM · Traditional | 3M Company | 03/16/1994SE |
| K935082 | 3M Dental Electronic Anesthesia (Dea) System 8670 ModificationLWM · Traditional | 3M Company | 01/26/1994SE |
| K915717 | CedetaLWM · Traditional | D-W Intl. | 11/23/1992SE |
| K920119 | 3M Dental Electronic Anesthesia SystemLWM · Traditional | 3M Company | 05/22/1992SE |
| K910625 | UltracalmLWM · Traditional | Sion Technology, Inc. | 05/15/1992SE |
| K902948 | Comfortron II (TENS)LWM · Traditional | M. D. Products | 12/17/1990SE |
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Questions and answers
When was 3M Dental Electrononic Anesthesia (DEA0 System 8670 Additional Applications cleared by the FDA?
3M Dental Electrononic Anesthesia (DEA0 System 8670 Additional Applications (K935085) received a 510(k) decision of Substantially Equivalent on January 26, 1994, 96 days after the submission was received.
What is the product code of K935085?
The FDA product code is LWM – Device, Electrical Dental Anesthesia, a Unclassified device.