FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
K Number: K101029
·
Decision Aug 16, 2010
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
54
Applicant Total
2
Review Days
125
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Basic Information
- Device Name
- KAIFENG/CRYSTAL, KAILI, KAIJING, KAIYUE, MAIST AND KAITONG/ROYAL SYNTHETIC POLYMER TEETH
- K Number
- K101029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3590
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huge Dental Material Co., Ltd.
- Date Received
- April 13, 2010
- Decision Date
- August 16, 2010
- Product Code
- ELM
- 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 |
|---|---|---|---|
| ELM | Denture, Plastic, Teeth | FDA class 2 | Dental |
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Other Clearances by Huge Dental Material Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201683 | PMMA Block | Nov 3, 2020 | Substantially Equivalent |