FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIT Clear Aligner
K Number: K210613
·
Decision Jun 4, 2021
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
6
Review Days
95
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Basic Information
- Device Name
- HIT Clear Aligner
- K Number
- K210613
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cdb Corporation
- Date Received
- March 1, 2021
- Decision Date
- June 4, 2021
- Product Code
- NXC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NXC | Aligner, Sequential | FDA class 2 | Dental |
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Other Clearances by Cdb Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K212173 | HDH Treatment Planning System | Jan 25, 2022 | Substantially Equivalent |
| K191823 | Clear-Aligners | Dec 20, 2019 | Substantially Equivalent |
| K160957 | CDB Self Ligating Bracket 8F | Sep 27, 2016 | Substantially Equivalent |
| K091702 | CDB FLIP-SIDE-CLIP BRACKET | Aug 7, 2009 | Substantially Equivalent |
| K080906 | CDB CLIP | Oct 17, 2008 | Substantially Equivalent |