FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
IMPREGUM PENTA
K Number: K954192
·
Decision Dec 1, 1995
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
401
Applicant Total
17
Review Days
86
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Basic Information
- Device Name
- IMPREGUM PENTA
- K Number
- K954192
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Espe GmbH & Co. Kg.
- Date Received
- September 6, 1995
- Decision Date
- December 1, 1995
- Product Code
- ELW
- 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 |
|---|---|---|---|
| ELW | Material, Impression | FDA class 2 | Dental |
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Other Clearances by Espe GmbH & Co. Kg.
| K Number | Device Name | ||
|---|---|---|---|
| K974231 | POSITION PENTA, POSITION PENTA QUICK | Jan 29, 1998 | Substantially Equivalent |
| K973513 | SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER | Dec 22, 1997 | Substantially Equivalent |
| K973262 | KETAC-FIL APLICAP PLUS | Nov 17, 1997 | Substantially Equivalent |
| K972892 | CAVIT-LC | Oct 2, 1997 | Substantially Equivalent |
| K963735 | COJET SYSTEM | Nov 27, 1996 | Substantially Equivalent |
| K963737 | HYCEM APLICAP | Nov 15, 1996 | Substantially Equivalent |
| K962428 | EBS (ESPE BONDING SYSTEM) | Sep 12, 1996 | Substantially Equivalent |
| K962442 | HYTAC APLITIP/HYTAC OSB | Sep 11, 1996 | Substantially Equivalent |
| K962440 | PERTAC II/PERTAC II APLITIP | Sep 11, 1996 | Substantially Equivalent |
| K960954 | KETAC-MOLAR APLICAP | May 16, 1996 | Substantially Equivalent |