FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN
K Number: K070699
·
Decision Jun 29, 2007
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
2
Review Days
108
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Basic Information
- Device Name
- AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN
- K Number
- K070699
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pentron Ceramics, Inc.
- Date Received
- March 13, 2007
- Decision Date
- June 29, 2007
- 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 Pentron Ceramics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K081749 | AVANTE Z ZIRCONIA (AS)3 BLOCKS | Sep 30, 2008 | Substantially Equivalent |