FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
INCORIS TZI
K Number: K123545
·
Decision Feb 1, 2013
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
42
Review Days
74
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INCORIS TZI
- K Number
- K123545
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sirona Dental Systems GmbH
- Date Received
- November 19, 2012
- Decision Date
- February 1, 2013
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EIH), ordered by most recent decision date.
Rosetta SM, Rosetta SP
FDA 510(k)
FDA Class 2
·Dental
DCMhotbond zircon
FDA 510(k)
FDA Class 2
·Dental
Eternal Art Porcelain Powders
FDA 510(k)
FDA Class 2
·Dental
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
FDA 510(k)
FDA Class 2
·Dental
IPS e.max Zirconia
FDA 510(k)
FDA Class 2
·Dental
BruxZir® Shaded 16 PLUS
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Sirona Dental Systems GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K160099 | CEREC SpeedGlaze | Jun 2, 2016 | Substantially Equivalent |
| K151045 | TENEO Dental Treatment Unit and Accessories | Jul 24, 2015 | Substantially Equivalent |
| K150909 | INTEGO Family and Accesories | Jul 17, 2015 | Substantially Equivalent |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Jul 2, 2015 | Substantially Equivalent |
| K150217 | ORTHOPHOS SL | May 8, 2015 | Substantially Equivalent |
| K131319 | T1/T2/T3 TURBINE FAMILY | May 30, 2014 | Substantially Equivalent |
| K132773 | SIDEXIS 4 | Dec 11, 2013 | Substantially Equivalent |
| K123664 | INCORIS ZI | Apr 8, 2013 | Substantially Equivalent |
| K123952 | CEREC BLOCS C IN | Mar 20, 2013 | Substantially Equivalent |
| K123070 | GALILEOS FAMILY | Mar 15, 2013 | Substantially Equivalent |