FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENTAL AMALGAM ALLOY (SPHERICAL II)
K Number: K760379
·
Decision Aug 23, 1976
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
193
Applicant Total
20
Review Days
18
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
- DENTAL AMALGAM ALLOY (SPHERICAL II)
- K Number
- K760379
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- L.D. Caulk Co.
- Date Received
- August 5, 1976
- Decision Date
- August 23, 1976
- Product Code
- EJS
- 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 |
|---|---|---|---|
| EJS | Alloy, Other Noble Metal | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EJS), ordered by most recent decision date.
BRIGHT GOLD XH
FDA 510(k)
FDA Class 2
·Dental
SIMIDUR SUPERIOR
FDA 510(k)
FDA Class 2
·Dental
STERNGOLD 1, MODEL 1127781
FDA 510(k)
FDA Class 2
·Dental
ECO E4
FDA 510(k)
FDA Class 2
·Dental
STERNGOLD 66, MODEL #1180230
FDA 510(k)
FDA Class 2
·Dental
SIMIDUR S1S
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 |