FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CERANA
K Number: K992161
·
Decision Sep 22, 1999
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
4
Review Days
89
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
- CERANA
- K Number
- K992161
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nordiska Dental AB
- Date Received
- June 25, 1999
- Decision Date
- September 22, 1999
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EIH), ordered by most recent decision date.
Rosetta SM, Rosetta SP
FDA 510(k)
FDA Class 2
·Dental
DCMhotbond zircon
FDA 510(k)
FDA Class 2
·Dental
Eternal Art Porcelain Powders
FDA 510(k)
FDA Class 2
·Dental
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
FDA 510(k)
FDA Class 2
·Dental
IPS e.max Zirconia
FDA 510(k)
FDA Class 2
·Dental
BruxZir® Shaded 16 PLUS
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Nordiska Dental AB
| K Number | Device Name | ||
|---|---|---|---|
| K002810 | ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY | Oct 31, 2000 | Substantially Equivalent |
| K002808 | ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY | Oct 31, 2000 | Substantially Equivalent |
| K002811 | ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY | Oct 31, 2000 | Substantially Equivalent |