FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IPS CERAMIC ETCHING GEL
K Number: K923926
·
Decision Oct 27, 1992
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
131
Review Days
83
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Basic Information
- Device Name
- IPS CERAMIC ETCHING GEL
- K Number
- K923926
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ivoclar North America, Inc.
- Date Received
- August 5, 1992
- Decision Date
- October 27, 1992
- Product Code
- ELL
- 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 |
|---|---|---|---|
| ELL | Teeth, Porcelain | FDA class 2 | Dental |
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|---|---|---|---|
| K012174 | ERIS LAYERING MATERIALS | Aug 27, 2001 | Substantially Equivalent |
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| 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 |