FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SABER TECH IMPLANTS SYSTEM
K Number: K024044
·
Decision Feb 21, 2003
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
28
Review Days
77
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Basic Information
- Device Name
- SABER TECH IMPLANTS SYSTEM
- K Number
- K024044
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Imtec Corp.
- Date Received
- December 6, 2002
- Decision Date
- February 21, 2003
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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|---|---|---|---|
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| K053046 | ILUMA ORTHOCAT/DENTALCAT | Nov 8, 2005 | Substantially Equivalent |
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| K042289 | MDI ORTHO | Sep 15, 2004 | Substantially Equivalent |
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| K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | Apr 23, 2003 | Substantially Equivalent |
| K023067 | IMTEC SENDAX MDI ORTHO6 AND ORTHO8 | Dec 3, 2002 | Substantially Equivalent |