FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DENTAL AMALGAMATOR
K Number: K780560
·
Decision Apr 21, 1978
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
14
Applicant Total
20
Review Days
16
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Basic Information
- Device Name
- DENTAL AMALGAMATOR
- K Number
- K780560
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.3100
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- L.D. Caulk Co.
- Date Received
- April 5, 1978
- Decision Date
- April 21, 1978
- Product Code
- EFD
- 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 |
|---|---|---|---|
| EFD | Amalgamator, Dental, Ac-Powered | FDA class 1 | Dental |
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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 |
| 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 |