FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOSIT N
K Number: K864710
·
Decision Feb 10, 1987
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
11
Review Days
70
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Basic Information
- Device Name
- ISOSIT N
- K Number
- K864710
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ivoclar USA, Inc.
- Date Received
- December 2, 1986
- Decision Date
- February 10, 1987
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Ivoclar USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012877 | HIGH GOLD PALLADIUM FREE CERAMIC SOLDER | Nov 21, 2001 | Substantially Equivalent |
| K981264 | ARISTON PHC | Jul 2, 1998 | Substantially Equivalent |
| K980986 | PROCAD | May 11, 1998 | Substantially Equivalent |
| 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 |
| 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 |