FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMPOSITE DENTAL RESTORATIVE MATERIAL
K Number: K813090
·
Decision Nov 24, 1981
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
15
Review Days
22
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Basic Information
- Device Name
- COMPOSITE DENTAL RESTORATIVE MATERIAL
- K Number
- K813090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sci-Pharm, Inc.
- Date Received
- November 2, 1981
- Decision Date
- November 24, 1981
- 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 Sci-Pharm, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823935 | MICRO JOIN, CROWN & BRIDGE ADHESIVE | Feb 7, 1983 | Substantially Equivalent |
| K820092 | SECURE-ON-TOUCH | Feb 24, 1982 | Substantially Equivalent |
| K813091 | FISSURE SEALER & BONDING AGENT | Nov 24, 1981 | Substantially Equivalent |
| K812550 | BEAUCAV | Sep 25, 1981 | Substantially Equivalent |
| K812545 | BEAUFILL | Sep 25, 1981 | Substantially Equivalent |
| K812546 | BEAUDENT | Sep 25, 1981 | Substantially Equivalent |
| K812548 | COBEAU | Sep 25, 1981 | Substantially Equivalent |
| K812549 | BEAUSEAL | Sep 25, 1981 | Substantially Equivalent |
| K812551 | BEAUCOR | Sep 23, 1981 | Substantially Equivalent |
| K812547 | BEAUBON | Sep 23, 1981 | Substantially Equivalent |