FDA product code LWM: Device, Electrical Dental Anesthesia
LWM is the FDA product code for device, electrical dental anesthesia. It is a Unclassified device, reviewed by the Dental panel. FDA has cleared 15 510(k) submissions under LWM, from 10 different applicants. The average 510(k) review took 175 days (median 134).
Classification
| Field | Value |
|---|---|
| Device name | Device, Electrical Dental Anesthesia |
| Device class | Unclassified |
| Review panel | DE — Dental |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LWM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 154 |
| 2020 | 2 | 78 |
Compare with all 510(k) review times · Search every LWM clearance
Top LWM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3M Company | 4 | 1994-03-16 |
| Synapse Dental | 2 | 2020-01-17 |
| M. D. Products | 2 | 1990-12-17 |
| Synapse Dental, LLC | 1 | 2019-03-26 |
| Satelec | 1 | 2001-06-07 |
5 more applicants have LWM clearances. See the full list in Caduvo.
Most recent LWM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193570 | Synapse Dental | Dental Pain Eraser | 2020-01-17 | 25 |
| K192429 | Synapse Dental | Dental Pain Eraser | 2020-01-14 | 131 |
| K182947 | Synapse Dental, LLC | Dental Pain Eraser | 2019-03-26 | 154 |
| K011001 | Satelec | TEAM-UP TM DENTAL ELECTRONIC ANESTHESIA SYSTEM | 2001-06-07 | 90 |
| K935304 | 3M Company | 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 | 1994-03-16 | 134 |
Recalls for LWM devices
openFDA lists no recalls for product code LWM.
Frequently asked questions
What is FDA product code LWM?
LWM is the FDA product code for device, electrical dental anesthesia. It is a Unclassified device, reviewed by the Dental panel.
What device class is LWM?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LWM?
Across 15 cleared submissions the average was 175 days from receipt to decision (median 134).
Which companies have the most LWM clearances?
3M Company (4); Synapse Dental (2); M. D. Products (2); Synapse Dental, LLC (1); Satelec (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LWM
- Run a recall and safety report across every LWM manufacturer
- Watch product code LWM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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