FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CZR PRESS LF STAINS
K Number: K050920
·
Decision May 11, 2005
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
471
Applicant Total
14
Review Days
29
Basic Information
- Device Name
- CZR PRESS LF STAINS
- K Number
- K050920
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- NORITAKE CO., INC.
- Date Received
- April 12, 2005
- Decision Date
- May 11, 2005
- 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 |
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Other Clearances by NORITAKE CO., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K111383 | ZIRPRIME | Aug 12, 2011 | Substantially Equivalent |
| K111107 | SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE | Jun 30, 2011 | Substantially Equivalent |
| K052304 | SUPER PORCELAIN EX-3 PRESS | Nov 23, 2005 | Substantially Equivalent |
| K050160 | KATANA ZIRCONIA | Feb 7, 2005 | Substantially Equivalent |
| K043462 | CZR PRESS LF | Jan 11, 2005 | Substantially Equivalent |
| K031968 | CERABIEN ZR | Dec 22, 2003 | Substantially Equivalent |
| K033049 | CZR PRESS | Oct 24, 2003 | Substantially Equivalent |
| K992023 | GRAND CERAM | Sep 3, 1999 | Substantially Equivalent |
| K992024 | SUPER PORCELAIN TI-22 | Aug 27, 1999 | Substantially Equivalent |
| K983470 | SUPER PORCELAIN STAIN- PURE WHITE | Dec 22, 1998 | Substantially Equivalent |