FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
K Number: K030243
·
Decision Apr 23, 2003
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
28
Review Days
90
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Basic Information
- Device Name
- ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314
- K Number
- K030243
- 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
- January 23, 2003
- Decision Date
- April 23, 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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Other Clearances by Imtec Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K081653 | MDI MII ONE-PIECE IMPLANT, 2.9MM | Sep 19, 2008 | Substantially Equivalent |
| K081347 | ILUMA VISION | May 28, 2008 | Substantially Equivalent |
| K072660 | ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114 | Dec 12, 2007 | Substantially Equivalent |
| K053046 | ILUMA ORTHOCAT/DENTALCAT | Nov 8, 2005 | Substantially Equivalent |
| K043226 | ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320 | Jan 13, 2005 | Substantially Equivalent |
| K042289 | MDI ORTHO | Sep 15, 2004 | Substantially Equivalent |
| K033432 | LEXATITE QUICK ACRYLIC | Jan 15, 2004 | Substantially Equivalent |
| K031106 | IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX | Aug 12, 2003 | Substantially Equivalent |
| K024044 | SABER TECH IMPLANTS SYSTEM | Feb 21, 2003 | Substantially Equivalent |
| K023067 | IMTEC SENDAX MDI ORTHO6 AND ORTHO8 | Dec 3, 2002 | Substantially Equivalent |