FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Luminesse PMMA
K Number: K142371
·
Decision Apr 24, 2015
Classifications
1
FEI Numbers
180
Registration Numbers
180
Same Product Code
188
Applicant Total
7
Review Days
242
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Basic Information
- Device Name
- Luminesse PMMA
- K Number
- K142371
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Talladium, Inc.
- Date Received
- August 25, 2014
- Decision Date
- April 24, 2015
- Product Code
- EBG
- 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 |
|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | FDA class 2 | Dental |
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Other Clearances by Talladium, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K152023 | Luminesse Shaded Zirconia SZ | Sep 15, 2016 | Substantially Equivalent |
| K152066 | Luminesse Anterior Zirconia AT | Oct 21, 2015 | Substantially Equivalent |
| K143090 | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID | Jun 15, 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 |