FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRYSTAL-BOND
K Number: K810241
·
Decision Feb 12, 1981
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
2
Review Days
15
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Basic Information
- Device Name
- CRYSTAL-BOND
- K Number
- K810241
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- American Ormco
- Date Received
- January 28, 1981
- Decision Date
- February 12, 1981
- 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 American Ormco
| K Number | Device Name | ||
|---|---|---|---|
| K812300 | LINGUAL BRACKET | Sep 21, 1981 | Substantially Equivalent |