FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VALIANT
K Number: K801690
·
Decision Aug 13, 1980
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
73
Applicant Total
20
Review Days
21
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Basic Information
- Device Name
- VALIANT
- K Number
- K801690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3070
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- L.D. Caulk Co.
- Date Received
- July 23, 1980
- Decision Date
- August 13, 1980
- Product Code
- EJJ
- 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 |
|---|---|---|---|
| EJJ | Alloy, Amalgam | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJJ), ordered by most recent decision date.
SILVERFIL
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BENCO ADMIX
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BENCO SPHERICAL
FDA 510(k)
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HIGH SILVER CONVENTIONAL
FDA 510(k)
FDA Class 2
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Other Clearances by L.D. Caulk Co.
| K Number | Device Name | ||
|---|---|---|---|
| K802262 | COMPOSITE RESTORATIVE | Sep 16, 1980 | Unknown |
| 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 |
| K771400 | IMPREGNATED DENTAL FLOSS | Aug 22, 1977 | Substantially Equivalent |