3M Dental Electronic Anesthesia System
FDA 510(k) K920119 · 3M Company
510(k) numberK920119
Submission
- Device name
- 3M Dental Electronic Anesthesia System
- Applicant
- 3M Company
Cottae Grove, MN, US - Received
- January 10, 1992
- Decision date
- May 22, 1992
- 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 |
| K935085 | 3M Dental Electrononic Anesthesia (DEA0 System 8670 Additional ApplicationsLWM · Traditional | 3M Company | 01/26/1994SE |
| K935082 | 3M Dental Electronic Anesthesia (Dea) System 8670 ModificationLWM · Traditional | 3M Company | 01/26/1994SE |
| K915717 | CedetaLWM · Traditional | D-W Intl. | 11/23/1992SE |
| 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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| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 10/18/2024SE |
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| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was 3M Dental Electronic Anesthesia System cleared by the FDA?
3M Dental Electronic Anesthesia System (K920119) received a 510(k) decision of Substantially Equivalent on May 22, 1992, 133 days after the submission was received.
What is the product code of K920119?
The FDA product code is LWM – Device, Electrical Dental Anesthesia, a Unclassified device.