FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GC TION GINGIVAL PROTECTOR
K Number: K043301
·
Decision Jan 25, 2005
Classifications
1
FEI Numbers
110
Registration Numbers
110
Same Product Code
32
Applicant Total
127
Review Days
56
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Basic Information
- Device Name
- GC TION GINGIVAL PROTECTOR
- K Number
- K043301
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6300
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- GC America, Inc.
- Date Received
- November 30, 2004
- Decision Date
- January 25, 2005
- Product Code
- EIE
- 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 |
|---|---|---|---|
| EIE | Dam, Rubber | FDA class 1 | Dental |
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