FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CDB CLIP
K Number: K080906
·
Decision Oct 17, 2008
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
59
Applicant Total
6
Review Days
199
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CDB CLIP
- K Number
- K080906
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cdb Corporation
- Date Received
- April 1, 2008
- Decision Date
- October 17, 2008
- Product Code
- NJM
- 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 |
|---|---|---|---|
| NJM | Bracket, Ceramic, Orthodontic | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NJM), ordered by most recent decision date.
LightForce Orthodontic System
FDA 510(k)
FDA Class 2
·Dental
Cleo
FDA 510(k)
FDA Class 2
·Dental
A-Line Advanced
FDA 510(k)
FDA Class 2
·Dental
DynaFlex Clear Brackets & Buttons
FDA 510(k)
FDA Class 2
·Dental
Ceramic Brackets Orthometric
FDA 510(k)
FDA Class 2
·Dental
LightForce Orthodontic System
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Cdb Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K212173 | HDH Treatment Planning System | Jan 25, 2022 | Substantially Equivalent |
| K210613 | HIT Clear Aligner | Jun 4, 2021 | 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 |