FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPARTAN SOLDER
K Number: K854738
·
Decision Mar 6, 1986
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
26
Review Days
101
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Basic Information
- Device Name
- SPARTAN SOLDER
- K Number
- K854738
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Williams Gold Refining Co., Inc.
- Date Received
- November 25, 1985
- Decision Date
- March 6, 1986
- Product Code
- EJH
- 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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | FDA class 2 | Dental |
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Other Clearances by Williams Gold Refining Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K855182 | ALLOY FOR METAL CROWN & BRIDGE YELLOW PD #46 & #65 | Mar 25, 1986 | Substantially Equivalent |
| K860439 | DW217 #18 CROWN/BRIDGE & DW218 #24 CERAMIC ALLOYS | Mar 20, 1986 | Substantially Equivalent |
| K852895 | CERAMIC ALLOY NO. DW 179 | Oct 21, 1985 | Substantially Equivalent |
| K852093 | ALLOY 7 | Aug 23, 1985 | Substantially Equivalent |
| K850699 | SPARTAN -ALLOY FOR PORCELAIN FUSED TO METAL | Mar 18, 1985 | Substantially Equivalent |
| K844394 | RENAISSANCE BONDING AGENT | Jan 9, 1985 | Substantially Equivalent |
| K844395 | RENAISSANCE | Jan 9, 1985 | Substantially Equivalent |
| K822419 | NEW CROWN AND BRIDGE ALLOY NO. DW196 | Aug 30, 1982 | Substantially Equivalent |
| K821510 | A THENIUM | Jun 9, 1982 | Substantially Equivalent |
| K811563 | PRESOLDER FOR NON-PRECIOUS DENTAL ALLOYS | Jul 28, 1981 | Substantially Equivalent |