FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
K Number: K003219
·
Decision Oct 25, 2000
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
34
Applicant Total
3
Review Days
9
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Basic Information
- Device Name
- HARALD NORDIN CARBONITE CARBON FIBER COMPOSITE DENTAL POST
- K Number
- K003219
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 872.3810
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Harald Nordin S.A
- Date Received
- October 16, 2000
- Decision Date
- October 25, 2000
- Product Code
- ELR
- 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 |
|---|---|---|---|
| ELR | Post, Root Canal | FDA class 1 | Dental |
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