FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUMEASE DENTAL MOUTHPIECE
K Number: K072082
·
Decision Nov 5, 2007
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
26
Applicant Total
1
Review Days
98
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Basic Information
- Device Name
- GUMEASE DENTAL MOUTHPIECE
- K Number
- K072082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5550
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Biomedevice , Ltd.
- Date Received
- July 30, 2007
- Decision Date
- November 5, 2007
- Product Code
- KKO
- 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 |
|---|---|---|---|
| KKO | Ring, Teething, Fluid-Filled | FDA class 2 | Dental |
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