FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILUMA ORTHOCAT/DENTALCAT
K Number: K053046
·
Decision Nov 8, 2005
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
28
Review Days
11
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Basic Information
- Device Name
- ILUMA ORTHOCAT/DENTALCAT
- K Number
- K053046
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Imtec Corp.
- Date Received
- October 28, 2005
- Decision Date
- November 8, 2005
- Product Code
- JAK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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|---|---|---|---|
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| 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 |
| K030243 | ENDURE IMPLANT, MODEL 3508,3511,3514,4308,4311,4314 | Apr 23, 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 |