FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
Chang Gung ComMed Series Dental Implant System
K Number: K142751
·
Decision Jun 15, 2015
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
2
Review Days
264
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Basic Information
- Device Name
- Chang Gung ComMed Series Dental Implant System
- K Number
- K142751
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Chang Gung Medical Technology Co., Ltd.
- Date Received
- September 24, 2014
- Decision Date
- June 15, 2015
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by Chang Gung Medical Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K142982 | OPUS 5100 Diagnostic Doppler Ultrasound System | Sep 3, 2015 | Substantially Equivalent |