FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WILLI GELLER CREATION & AV PORCELAIN
K Number: K002041
·
Decision Aug 16, 2000
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
17
Review Days
42
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Basic Information
- Device Name
- WILLI GELLER CREATION & AV PORCELAIN
- K Number
- K002041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jensen Industries, Inc.
- Date Received
- July 5, 2000
- Decision Date
- August 16, 2000
- 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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| K070114 | CREATION CP-ZI PORCELAIN | Mar 1, 2007 | Substantially Equivalent |
| K050838 | THE LF-P CERAMIC SYSTEM | May 4, 2005 | Substantially Equivalent |
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| K043221 | WILLI GELLER CREATION CP PORCELAIN | Dec 20, 2004 | Substantially Equivalent |
| K032267 | R&D DESIGNATION AP-052-5 | Sep 17, 2003 | Substantially Equivalent |
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