FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANT. & POST. RESTORATIVE POWDER LIQ.
K Number: K800390
·
Decision Apr 10, 1980
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
5
Review Days
50
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Basic Information
- Device Name
- ANT. & POST. RESTORATIVE POWDER LIQ.
- K Number
- K800390
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- American Dental Research
- Date Received
- February 20, 1980
- Decision Date
- April 10, 1980
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | FDA class 2 | Dental |
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Other Clearances by American Dental Research
| K Number | Device Name | ||
|---|---|---|---|
| K800393 | POLY SULFIDE IMPRESSION PASTE W/CATALYST | Apr 10, 1980 | Substantially Equivalent |
| K800389 | ANTERIOR & POST. RESTORATIVE PASTE SYS. | Apr 10, 1980 | Substantially Equivalent |
| K800391 | PAINT-ON-RESTORATIVE W/FISSURE SEALER | Apr 10, 1980 | Substantially Equivalent |
| K800392 | BRACKET BONDING SYSTEM METAL & PLASTIC | Apr 10, 1980 | Substantially Equivalent |