FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TCS UNBREAKABLE
K Number: K053060
·
Decision Jul 20, 2006
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
329
Applicant Total
3
Review Days
262
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Basic Information
- Device Name
- TCS UNBREAKABLE
- K Number
- K053060
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Thermoplastic Comfort Systems, Inc.
- Date Received
- October 31, 2005
- Decision Date
- July 20, 2006
- Product Code
- EBI
- 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 |
|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | FDA class 2 | Dental |
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