FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
DENU Composite Resin, DENU Flow Resin
K Number: K213339
·
Decision Sep 23, 2022
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
2
Review Days
351
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Basic Information
- Device Name
- DENU Composite Resin, DENU Flow Resin
- K Number
- K213339
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hdi, Inc.
- Date Received
- October 7, 2021
- Decision Date
- September 23, 2022
- Product Code
- EBF
- 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | FDA class 2 | Dental |
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Other Clearances by Hdi, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | Nov 7, 2022 | Substantially Equivalent |