FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
K Number: K143090
·
Decision Jun 15, 2015
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
7
Review Days
230
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Basic Information
- Device Name
- LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID
- K Number
- K143090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Talladium, Inc.
- Date Received
- October 28, 2014
- Decision Date
- June 15, 2015
- 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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| K142371 | Luminesse PMMA | Apr 24, 2015 | Substantially Equivalent |
| K140848 | LUMINESSE PORCELAIN SYSTEM | Dec 17, 2014 | Substantially Equivalent |
| K100232 | LUMINESSE ZR BLANKS | May 21, 2010 | Substantially Equivalent |
| K894085 | TALLADIUM TILITE CERAMIC ALLOY | Dec 20, 1989 | Substantially Equivalent |