FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FISSURE SEALER
K Number: K913853
·
Decision Aug 27, 1992
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
130
Applicant Total
9
Review Days
366
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Basic Information
- Device Name
- FISSURE SEALER
- K Number
- K913853
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3765
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Ortho Source
- Date Received
- August 27, 1991
- Decision Date
- August 27, 1992
- 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 |
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Other Clearances by Ortho Source
| K Number | Device Name | ||
|---|---|---|---|
| K913854 | ORTHO LIGHT CURE | Jan 14, 1992 | Substantially Equivalent |
| K913519 | SUMO GLASS IONOMER CEMENT | Nov 19, 1991 | Substantially Equivalent |
| K884949 | VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINER | Feb 23, 1989 | Substantially Equivalent |
| K884575 | MAXIBOND | Jan 3, 1989 | Substantially Equivalent |
| K861118 | ORTHOJOIN, ORTHODONTIC ADHESIVE | May 2, 1986 | Substantially Equivalent |
| K861258 | PERMABAND (ORTHODONTIC ADHESIVE) | Apr 17, 1986 | Substantially Equivalent |
| K861245 | ORTHOSOURCE ETCH SYSTEMS | Apr 11, 1986 | Substantially Equivalent |
| K860959 | DEPENDABOND | Mar 25, 1986 | Substantially Equivalent |