FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISIO-GEM ART-SYSTEM
K Number: K905604
·
Decision Mar 29, 1991
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
59
Review Days
108
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Basic Information
- Device Name
- VISIO-GEM ART-SYSTEM
- K Number
- K905604
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Espe GmbH (Us)
- Date Received
- December 11, 1990
- Decision Date
- March 29, 1991
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | 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 |
| 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 |