Composite Resin Warmer
The Composite Resin Warmer is a dental device intended to warm composite resin materials prior to use in dental restorative procedures, improving the handling properties and application of the composite material. It is classified as FDA Class 1, with no premarket notification required (exempt), under regulation 872.6100 in the Dental specialty. The product code is QGO. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QGO
- Device Class
- FDA class 1
- Regulation Number
- 872.6100
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
Definition
Intended to warm composite materials prior to use
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K182017 | Compex HD | Apr 29, 2019 | Substantially Equivalent | Addent, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.