Product code MQC ยท Class U
Mouthguard, Prescription
3510(k)s in 12 months (72 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MQC
| Company | 510(k)s | Recalls |
|---|---|---|
| Pro3Dure Medical | 4 | 0 |
| Dental Concepts, LLC | 2 | 0 |
| Envisiontec GmbH | 2 | 0 |
| Formlabs Ohio, Inc. | 2 | 0 |
| Keystone Industries | 1 | 1 |
| Power Products, Inc.-Splintek | 2 | 0 |
| Prismatik Dentalcraft, Inc. | 2 | 0 |
| Whip Mix Corporation | 2 | 0 |
| 12th Man Technologies, Inc. | 1 | 0 |
| 3D Diagnostix, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 3, 2024 | Keystone Industries KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental
appliances such as mouthguards, nightguards, splints, repositioners, and retainers
Item No.: 4220011 Open, Classified |
MQC | K203000 |
| Jun 25, 2021 | Straumann USA LLC KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners.
Model (Ref) #: 4220005 Open, Classified |
MQC | K183598 |
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