FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
K Number: K052130
·
Decision Aug 15, 2005
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
36
Review Days
10
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Basic Information
- Device Name
- VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40
- K Number
- K052130
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vident
- Date Received
- August 5, 2005
- Decision Date
- August 15, 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 Vident
| K Number | Device Name | ||
|---|---|---|---|
| K063768 | TITANIUM SCALLOPED ABUTMENT | Jun 27, 2007 | Substantially Equivalent |
| K060441 | VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 | Apr 27, 2006 | Substantially Equivalent |
| K052710 | VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, | Jan 13, 2006 | Substantially Equivalent |
| K050362 | VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) | Mar 15, 2005 | Substantially Equivalent |
| K022996 | VITA IN-CERAM YZ CUBES FOR CEREC | Oct 9, 2002 | Substantially Equivalent |
| K012473 | VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT | Sep 11, 2002 | Substantially Equivalent |
| K000597 | VITA RESPONSE | May 17, 2000 | Substantially Equivalent |
| K990367 | PDQ AND PDQ-TI ABUTMENT | Apr 21, 1999 | Substantially Equivalent |
| K984198 | WIDE BODY ABUTMENTS | Feb 18, 1999 | Substantially Equivalent |
| K982664 | VITA TITANIUM PORCELAIN | Aug 2, 1998 | Substantially Equivalent |