FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
K Number: K022224
·
Decision Sep 18, 2002
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
192
Applicant Total
2
Review Days
70
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Basic Information
- Device Name
- COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM
- K Number
- K022224
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3750
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coltene AG
- Date Received
- July 10, 2002
- Decision Date
- September 18, 2002
- 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 Coltene AG
| K Number | Device Name | ||
|---|---|---|---|
| K041098 | COOL TEMP NATURAL | May 13, 2004 | Substantially Equivalent |