FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIGIS-XO
K Number: K024145
·
Decision Mar 7, 2003
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
15
Review Days
81
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Basic Information
- Device Name
- AIGIS-XO
- K Number
- K024145
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sb Lucius, Inc.
- Date Received
- December 16, 2002
- Decision Date
- March 7, 2003
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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Other Clearances by Sb Lucius, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031010 | MIRACLE 98 | Jun 25, 2003 | Substantially Equivalent |
| K024143 | AIGIS-FINE | Mar 10, 2003 | Substantially Equivalent |
| K024142 | AIGIS-SUPER | Mar 10, 2003 | Substantially Equivalent |
| K024136 | AIGIS-SOFT | Mar 10, 2003 | Substantially Equivalent |
| K024135 | AIGIS-PLUS | Mar 10, 2003 | Substantially Equivalent |
| K024144 | AIGIS-PT | Mar 7, 2003 | Substantially Equivalent |
| K024139 | AIGIS-INLAY | Mar 7, 2003 | Substantially Equivalent |
| K024141 | NEO 76 | Mar 6, 2003 | Substantially Equivalent |
| K024140 | AIGIS-A | Mar 6, 2003 | Substantially Equivalent |
| K023197 | CERANUM 82 | Nov 5, 2002 | Substantially Equivalent |