FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE LF-P CERAMIC SYSTEM
K Number: K050838
·
Decision May 4, 2005
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
17
Review Days
33
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Basic Information
- Device Name
- THE LF-P CERAMIC SYSTEM
- K Number
- K050838
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jensen Industries, Inc.
- Date Received
- April 1, 2005
- Decision Date
- May 4, 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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|---|---|---|---|
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| K112806 | JENSEN ZIRCONIA | Dec 1, 2011 | Substantially Equivalent |
| K111743 | THE INSYNC CERAMIC SYSTEM | Sep 14, 2011 | Substantially Equivalent |
| K070114 | CREATION CP-ZI PORCELAIN | Mar 1, 2007 | Substantially Equivalent |
| K043201 | WILLI GELLER CREATION ZI PORCELAIN | Jan 11, 2005 | Substantially Equivalent |
| K043221 | WILLI GELLER CREATION CP PORCELAIN | Dec 20, 2004 | Substantially Equivalent |
| K032267 | R&D DESIGNATION AP-052-5 | Sep 17, 2003 | Substantially Equivalent |
| K022206 | JENSEN GOLD FOIL | Aug 29, 2002 | Substantially Equivalent |
| K010160 | WILLI GELLER CREAPEARL | Mar 27, 2001 | Substantially Equivalent |