FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ESPE CAPMIX
K Number: K891064
·
Decision May 30, 1989
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
14
Applicant Total
59
Review Days
90
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Basic Information
- Device Name
- ESPE CAPMIX
- K Number
- K891064
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3100
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Espe GmbH (Us)
- Date Received
- March 1, 1989
- Decision Date
- May 30, 1989
- Product Code
- EFD
- 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 |
|---|---|---|---|
| EFD | Amalgamator, Dental, Ac-Powered | FDA class 1 | Dental |
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Other Clearances by Espe GmbH (Us)
| K Number | Device Name | ||
|---|---|---|---|
| K925027 | PHOTAC-FIL APLICAP | Jun 18, 1993 | Substantially Equivalent |
| 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 |