FDA product code QGO: Composite Resin Warmer
QGO is the FDA product code for composite resin warmer. It is a Class I device, regulated under 21 CFR 872.6100 and reviewed by the Dental panel. FDA has cleared 1 510(k) submission under QGO. The average 510(k) review took 276 days (median 276).
Definition
Intended to warm composite materials prior to use
Classification
| Field | Value |
|---|---|
| Device name | Composite Resin Warmer |
| Device class | Class I |
| Regulation | 21 CFR 872.6100 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
510(k) clearances per year for QGO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 276 |
Compare with all 510(k) review times · Search every QGO clearance
Top QGO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Addent, Inc. | 1 | 2019-04-29 |
Most recent QGO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K182017 | Addent, Inc. | Compex HD | 2019-04-29 | 276 |
Recalls for QGO devices
openFDA lists no recalls for product code QGO.
Frequently asked questions
What is FDA product code QGO?
QGO is the FDA product code for composite resin warmer. It is a Class I device, regulated under 21 CFR 872.6100 and reviewed by the Dental panel.
What device class is QGO?
Class I, regulation 21 CFR 872.6100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code QGO?
Across 1 cleared submissions the average was 276 days from receipt to decision (median 276).
Which companies have the most QGO clearances?
Addent, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QGO
- Run a recall and safety report across every QGO manufacturer
- Watch product code QGO 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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