FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
K Number: K012877
·
Decision Nov 21, 2001
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
11
Review Days
86
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Basic Information
- Device Name
- HIGH GOLD PALLADIUM FREE CERAMIC SOLDER
- K Number
- K012877
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ivoclar USA, Inc.
- Date Received
- August 27, 2001
- Decision Date
- November 21, 2001
- Product Code
- EJT
- 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 |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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Other Clearances by Ivoclar USA, Inc.
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|---|---|---|---|
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| K941849 | PROVIPONT C&B | Aug 17, 1994 | Substantially Equivalent |
| K923644 | DW243-64 | Nov 4, 1992 | Substantially Equivalent |
| K864708 | SR 3/60 NF DENTURE MATER. & SELF-CURE DENT. RESIN | Feb 25, 1987 | Substantially Equivalent |
| K864710 | ISOSIT N | Feb 10, 1987 | Substantially Equivalent |
| K864707 | SR-VIVODENT ANTERIOR & SR-ORTHOTYP POSTERIOR TEETH | Feb 10, 1987 | Substantially Equivalent |
| K864709 | IVOCRYL HEAT CURE & IVOCRYL QUICK DENTURE MATERIAL | Feb 10, 1987 | Substantially Equivalent |
| K863421 | SR-IVOLEN TRAY MATERIAL | Nov 3, 1986 | Substantially Equivalent |
| K844349 | SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS | Dec 3, 1984 | Substantially Equivalent |