FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CAPA PRE-FORMED PORCELAIN CROWN
K Number: K852145
·
Decision Jul 2, 1985
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
38
Applicant Total
1
Review Days
47
Basic Information
- Device Name
- CAPA PRE-FORMED PORCELAIN CROWN
- K Number
- K852145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- CAPA INDUSTRIES
- Date Received
- May 16, 1985
- Decision Date
- July 2, 1985
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, Porcelain | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ELL), ordered by most recent decision date.
Additive Manufacturing Zirconia Customized Restoration
FDA 510(k)
FDA Class 2
·Dental
Franz Zirconia Dental Crown
FDA 510(k)
FDA Class 2
·Dental
NobelProcera HT ML FCZ Bridge
FDA 510(k)
FDA Class 2
·Dental
NobelProcera HT ML Full Contour Zirconia Crown
FDA 510(k)
FDA Class 2
·Dental
PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013
FDA 510(k)
FDA Class 2
·Dental
SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.
FDA 510(k)
FDA Class 2
·Dental