FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DENJECTOR
K Number: K081694
·
Decision Sep 12, 2008
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
44
Applicant Total
6
Review Days
87
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Basic Information
- Device Name
- DENJECTOR
- K Number
- K081694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.6770
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dxm Co., Ltd.
- Date Received
- June 17, 2008
- Decision Date
- September 12, 2008
- Product Code
- EJI
- 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 |
|---|---|---|---|
| EJI | Syringe, Cartridge | FDA class 2 | Dental |
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