FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISIO-DISPERS
K Number: K803227
·
Decision Jan 14, 1981
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
10
Review Days
26
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Basic Information
- Device Name
- VISIO-DISPERS
- K Number
- K803227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Espe-Premier Sales Co.
- Date Received
- December 19, 1980
- Decision Date
- January 14, 1981
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Espe-Premier Sales Co.
| K Number | Device Name | ||
|---|---|---|---|
| K812117 | PERMAGUM ADHESIVE | Aug 31, 1981 | Substantially Equivalent |
| K812116 | PERMAGUM | Aug 31, 1981 | Substantially Equivalent |
| K812115 | KETAC-CHEM | Aug 31, 1981 | Substantially Equivalent |
| K812118 | NIMETIC POLISHING PASTE | Aug 31, 1981 | Substantially Equivalent |
| K812119 | NIMETIC-DISPERS | Aug 31, 1981 | Substantially Equivalent |
| K811624 | VISIO-SEAL | Jun 26, 1981 | Substantially Equivalent |
| K810266 | ETCHING GEL | Feb 23, 1981 | Substantially Equivalent |
| K810265 | VISIO-BAND | Feb 23, 1981 | Substantially Equivalent |
| K803209 | ELIPAR LIGHT SOURCE | Jan 14, 1981 | Substantially Equivalent |