FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Novidia Bulk Fill Flow Composite
K Number: K182714
·
Decision Jul 12, 2019
Classifications
1
FEI Numbers
204
Registration Numbers
204
Same Product Code
931
Applicant Total
5
Review Days
288
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Basic Information
- Device Name
- Novidia Bulk Fill Flow Composite
- K Number
- K182714
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3690
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobio , Ltd.
- Date Received
- September 27, 2018
- Decision Date
- July 12, 2019
- 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 Nobio , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | Aug 14, 2020 | Substantially Equivalent |
| K183391 | Novidia Universal Bond | Sep 24, 2019 | Substantially Equivalent |
| K182921 | Infinix Universal Composite | Sep 13, 2019 | Substantially Equivalent |
| K182580 | Novidia Flowable Composite | Jul 3, 2019 | Substantially Equivalent |