QJKClass II
Intraoral Camera
21 CFR 872.3661 / Dental
QJK is the FDA product code for Intraoral Camera, a class II device type, regulated under 21 CFR 872.3661. FDA's definition for this code reads: "To capture the topographical characteristics of teeth or a stone model". As of , FDA records hold no 510(k) clearances under this code and no recalls.
Classification record
- Product code
- QJK
- Device name
- Intraoral Camera
- FDA definition
- To capture the topographical characteristics of teeth or a stone model
- Regulation
- 21 CFR 872.3661
- Device class
- Class II
- Review panel
- Dental
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 0
- Ingested recalls
- 0
Companies listing this code with FDA
Companies whose registered establishments list this code- A-dec, Inc.
- Acme Tooling Technology Co., Ltd.
- Align Technology de Costa Rica S.R.L
- Align Technology, Inc.
- Aligntech de Mexico S, de R. L. de C. V.
- Alliage S/A Industrias Medico Odontologica
- Beyes Dental Inc
- Clear Capture, LCC
- Denterprise International, Inc.
- Dongguan Yipincheng Technology Co., Ltd.
- DSM Holdings Co., Ltd
- Fabrinet Co., Ltd.
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