FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E-SARANG 86, DM78, DM55
K Number: K033435
·
Decision Nov 12, 2003
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
626
Applicant Total
4
Review Days
15
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Basic Information
- Device Name
- E-SARANG 86, DM78, DM55
- K Number
- K033435
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3060
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- We Dong Myung Dental Industrial Co., Ltd.
- Date Received
- October 28, 2003
- Decision Date
- November 12, 2003
- Product Code
- EJT
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EJT | Alloy, Gold-Based Noble Metal | FDA class 2 | Dental |
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