FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.
K Number: K904813
·
Decision May 31, 1991
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
6
Review Days
218
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Basic Information
- Device Name
- VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.
- K Number
- K904813
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Alpha-Dent
- Date Received
- October 25, 1990
- Decision Date
- May 31, 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 Alpha-Dent
| K Number | Device Name | ||
|---|---|---|---|
| K932828 | CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE | Feb 3, 1994 | Substantially Equivalent |
| K932829 | CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST | Jan 28, 1994 | Substantially Equivalent |
| K932826 | CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO | Jan 28, 1994 | Substantially Equivalent |
| K932827 | ALPHA-DENT CORE BUILDUP PASTE | Sep 23, 1993 | Substantially Equivalent |
| K904812 | COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE | Feb 26, 1991 | Substantially Equivalent |