FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERIS LAYERING MATERIALS
K Number: K012174
·
Decision Aug 27, 2001
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
481
Applicant Total
131
Review Days
46
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Basic Information
- Device Name
- ERIS LAYERING MATERIALS
- K Number
- K012174
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6660
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ivoclar North America, Inc.
- Date Received
- July 12, 2001
- Decision Date
- August 27, 2001
- Product Code
- EIH
- 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 |
|---|---|---|---|
| EIH | Powder, Porcelain | FDA class 2 | Dental |
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Other Clearances by Ivoclar North America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K003635 | DW 276 #3 | Dec 22, 2000 | Substantially Equivalent |