FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DAMON FT
K Number: K032408
·
Decision Oct 15, 2003
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
40
Applicant Total
106
Review Days
72
Basic Information
- Device Name
- DAMON FT
- K Number
- K032408
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SYBRON DENTAL SPECIALTIES, INC.
- Date Received
- August 4, 2003
- Decision Date
- October 15, 2003
- Product Code
- DYW
- 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 |
|---|---|---|---|
| DYW | Bracket, Plastic, Orthodontic | FDA class 2 | Dental |
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