FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVA-FIL COMPOSITE RESTORATIVE (MODI.)
K Number: K771404
·
Decision Aug 3, 1977
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
20
Review Days
5
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NUVA-FIL COMPOSITE RESTORATIVE (MODI.)
- K Number
- K771404
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- L.D. Caulk Co.
- Date Received
- July 29, 1977
- Decision Date
- August 3, 1977
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBF), ordered by most recent decision date.
SRGC-06
FDA 510(k)
FDA Class 2
·Dental
DIAFIL
FDA 510(k)
FDA Class 2
·Dental
DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
FDA 510(k)
FDA Class 2
·Dental
Dual Core
FDA 510(k)
FDA Class 2
·Dental
Dura-Crown
FDA 510(k)
FDA Class 2
·Dental
Grandio disc multicolor
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by L.D. Caulk Co.
| K Number | Device Name | ||
|---|---|---|---|
| K802262 | COMPOSITE RESTORATIVE | Sep 16, 1980 | Unknown |
| K801690 | VALIANT | Aug 13, 1980 | Substantially Equivalent |
| K790586 | CHEMBOND | May 16, 1979 | Substantially Equivalent |
| K790585 | FINESSE | May 16, 1979 | Substantially Equivalent |
| K780560 | DENTAL AMALGAMATOR | Apr 21, 1978 | Substantially Equivalent |
| K780384 | IMPROVED DYCAL | Mar 15, 1978 | Substantially Equivalent |
| K780301 | CAULK TYLOK | Feb 28, 1978 | Substantially Equivalent |
| K771398 | SHELL VENEER | Aug 26, 1977 | Substantially Equivalent |
| K771402 | NUVA-COTE (MODIFICATION TO) | Aug 26, 1977 | Substantially Equivalent |
| K771399 | LIP & CHEEK RETRACTOR | Aug 26, 1977 | Substantially Equivalent |