FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEPENDABOND
K Number: K860959
·
Decision Mar 25, 1986
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
9
Review Days
12
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Basic Information
- Device Name
- DEPENDABOND
- K Number
- K860959
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Ortho Source
- Date Received
- March 13, 1986
- Decision Date
- March 25, 1986
- Product Code
- DYH
- 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 |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | FDA class 2 | Dental |
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Other Clearances by Ortho Source
| K Number | Device Name | ||
|---|---|---|---|
| K913853 | FISSURE SEALER | Aug 27, 1992 | Substantially Equivalent |
| 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 |