FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
D-SIGN V (R&D PROJECT DW267#17)
K Number: K990182
·
Decision Mar 1, 1999
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
152
Applicant Total
131
Review Days
40
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Basic Information
- Device Name
- D-SIGN V (R&D PROJECT DW267#17)
- K Number
- K990182
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3710
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ivoclar North America, Inc.
- Date Received
- January 20, 1999
- Decision Date
- March 1, 1999
- 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 Ivoclar North America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K012174 | ERIS LAYERING MATERIALS | Aug 27, 2001 | Substantially Equivalent |
| K011491 | HELIOSEAL CLEAR CHROMA | Aug 16, 2001 | Substantially Equivalent |
| K011492 | IN TEN-S | Jul 5, 2001 | Substantially Equivalent |
| K011490 | MODIFICATION TO EXCITE | Jun 27, 2001 | Substantially Equivalent |
| K011023 | D.SIGN 96 | May 2, 2001 | Substantially Equivalent |
| K011022 | BIOUNIVERSAL PDF | May 2, 2001 | Substantially Equivalent |
| K010381 | D.SIGN 30 | Mar 6, 2001 | Substantially Equivalent |
| K010250 | TETRIC CERAM HB | Feb 28, 2001 | Substantially Equivalent |
| K003293 | EXCITE DSC | Feb 6, 2001 | Substantially Equivalent |
| K003407 | SYSTEMP.DESENSITIZER (VIVADENT.DESENSITIZER) | Jan 26, 2001 | Substantially Equivalent |