FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
IMAGINE H.E.
K Number: K012156
·
Decision Aug 16, 2001
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
14
Review Days
36
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
- IMAGINE H.E.
- K Number
- K012156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wieland Edelmetalle GmbH & Co.
- Date Received
- July 11, 2001
- Decision Date
- August 16, 2001
- 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 Wieland Edelmetalle GmbH & Co.
| K Number | Device Name | ||
|---|---|---|---|
| K020347 | AGC SPEZIALLEGIERUNG | Apr 24, 2002 | Substantially Equivalent |
| K012839 | AUROPAL, ORDER-NO.: 2101 | Dec 31, 2001 | Substantially Equivalent |
| K012841 | DUO PAL 6, ORDER-NO.: 2154 | Nov 20, 2001 | Substantially Equivalent |
| K012843 | PORTADUR P 2, MODEL #2031 | Nov 2, 2001 | Substantially Equivalent |
| K012828 | PORTA SMK 82, MODEL 2032 | Nov 1, 2001 | Substantially Equivalent |
| K012834 | PORTA GEO TI MODEL #2004 | Nov 1, 2001 | Substantially Equivalent |
| K012826 | BIOPORTA G, MODEL 2052 | Nov 1, 2001 | Substantially Equivalent |
| K012831 | BIO PORTADUR, ORDER-NO.:2017 | Nov 1, 2001 | Substantially Equivalent |
| K012827 | PORTA AURIUM, MODEL 2067 | Nov 1, 2001 | Substantially Equivalent |
| K012835 | PORTA MAXIMUM, MODEL# 2066 | Nov 1, 2001 | Substantially Equivalent |