FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICRODOSE SILANE
K Number: K924823
·
Decision Mar 16, 1993
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
38
Applicant Total
9
Review Days
169
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Basic Information
- Device Name
- MICRODOSE SILANE
- K Number
- K924823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3920
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Unicep
- Date Received
- September 28, 1992
- Decision Date
- March 16, 1993
- 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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Other Clearances by Unicep
| K Number | Device Name | ||
|---|---|---|---|
| K925163 | MICODOSE CHLORHEXIPREP | May 27, 1993 | Substantially Equivalent |
| K924821 | MICRODOSE PORCELAIN ETCHANT | Mar 16, 1993 | Substantially Equivalent |
| K924824 | MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE | Mar 16, 1993 | Substantially Equivalent |
| K925162 | MICRODOSE DENTIN CONDITIONER | Mar 16, 1993 | Substantially Equivalent |
| K924825 | MICRODOSE RC-EZ | Mar 5, 1993 | Substantially Equivalent |
| K924827 | MICRODOSE POTASSIUM OXYLATE | Mar 5, 1993 | Substantially Equivalent |
| K924822 | MICRODOSE ENAMEL ETCHANT | Mar 5, 1993 | Substantially Equivalent |
| K924826 | MICRODOSE TOTAL ETCHANT | Mar 5, 1993 | Substantially Equivalent |