FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Novidia Universal Bond
K Number: K183391
·
Decision Sep 24, 2019
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
5
Review Days
291
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Basic Information
- Device Name
- Novidia Universal Bond
- K Number
- K183391
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3200
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nobio , Ltd.
- Date Received
- December 7, 2018
- Decision Date
- September 24, 2019
- Product Code
- KLE
- 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 |
|---|---|---|---|
| KLE | Agent, Tooth Bonding, 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 |
| K182921 | Infinix Universal Composite | Sep 13, 2019 | Substantially Equivalent |
| K182714 | Novidia Bulk Fill Flow Composite | Jul 12, 2019 | Substantially Equivalent |
| K182580 | Novidia Flowable Composite | Jul 3, 2019 | Substantially Equivalent |