FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORTHO-SEAL
K Number: K883465
·
Decision Oct 12, 1988
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
88
Review Days
58
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Basic Information
- Device Name
- ORTHO-SEAL
- K Number
- K883465
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Bisco, Inc.
- Date Received
- August 15, 1988
- Decision Date
- October 12, 1988
- 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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