FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISIO-SEAL
K Number: K811624
·
Decision Jun 26, 1981
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
10
Review Days
17
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VISIO-SEAL
- K Number
- K811624
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Espe-Premier Sales Co.
- Date Received
- June 9, 1981
- Decision Date
- June 26, 1981
- Product Code
- EBC
- 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 |
|---|---|---|---|
| EBC | Sealant, Pit And Fissure, And Conditioner | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EBC), ordered by most recent decision date.
Any-Com Seal
FDA 510(k)
FDA Class 2
·Dental
Parkell Pit and Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio
FDA 510(k)
FDA Class 2
·Dental
Enamel Coating Resin
FDA 510(k)
FDA Class 2
·Dental
BA Pit & Fissure Sealant
FDA 510(k)
FDA Class 2
·Dental
Helioseal F Plus
FDA 510(k)
FDA Class 2
·Dental
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 |
| K810266 | ETCHING GEL | Feb 23, 1981 | Substantially Equivalent |
| K810265 | VISIO-BAND | Feb 23, 1981 | Substantially Equivalent |
| K803227 | VISIO-DISPERS | Jan 14, 1981 | Substantially Equivalent |
| K803209 | ELIPAR LIGHT SOURCE | Jan 14, 1981 | Substantially Equivalent |