FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
PHOTAC-FIL APLICAP
K Number: K925027
·
Decision Jun 18, 1993
Classifications
1
FEI Numbers
144
Registration Numbers
144
Same Product Code
504
Applicant Total
59
Review Days
259
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Basic Information
- Device Name
- PHOTAC-FIL APLICAP
- K Number
- K925027
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3275
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Espe GmbH (Us)
- Date Received
- October 2, 1992
- Decision Date
- June 18, 1993
- Product Code
- EMA
- 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 |
|---|---|---|---|
| EMA | Cement, Dental | FDA class 2 | Dental |
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Other Clearances by Espe GmbH (Us)
| K Number | Device Name | ||
|---|---|---|---|
| K915005 | PHOTAC-BOND APLICAP, MODIFICATION | Jan 14, 1992 | Substantially Equivalent |
| K913966 | SONO(R) -CEM | Jan 14, 1992 | Substantially Equivalent |
| K913857 | ROCATEC(R) -PLUS | Dec 16, 1991 | Substantially Equivalent |
| K913965 | ESPE(R) -SIL | Dec 4, 1991 | Substantially Equivalent |
| K905604 | VISIO-GEM ART-SYSTEM | Mar 29, 1991 | Substantially Equivalent |
| K904096 | PHOTAC-BOND | Nov 19, 1990 | Substantially Equivalent |
| K904097 | PHOTAC-BOND APLICAP | Nov 9, 1990 | Substantially Equivalent |
| K904289 | PERTAC UNIVERSAL BOND | Nov 1, 1990 | Substantially Equivalent |
| K900510 | PERTAC-HYBRID | Aug 9, 1990 | Substantially Equivalent |
| K900558 | PERTAC BOND | Apr 10, 1990 | Substantially Equivalent |