FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CreoDent Solidex Custom Abutment
K Number: K160436
·
Decision Sep 29, 2016
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
9
Review Days
225
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Basic Information
- Device Name
- CreoDent Solidex Custom Abutment
- K Number
- K160436
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Creodent Prosthetics, Ltd.
- Date Received
- February 17, 2016
- Decision Date
- September 29, 2016
- Product Code
- NHA
- 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 |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | FDA class 2 | Dental |
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Other Clearances by Creodent Prosthetics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220390 | CreoDent Solidex Customized Abutment and Screw | Dec 2, 2022 | Substantially Equivalent |
| K211427 | CREOKORREKT Aligners | Oct 13, 2022 | Substantially Equivalent |
| K202909 | CreoDent Solidex Customized Abutment | Apr 2, 2021 | Substantially Equivalent |
| K202095 | CreoDent Solidex Customized Abutment and Screw | Dec 16, 2020 | Substantially Equivalent |
| K170100 | CreoDent Solidex Customized Abutment and Screw | Jul 18, 2017 | Substantially Equivalent |
| K162734 | CreoDent Solidex Customized Abutment | May 8, 2017 | Substantially Equivalent |
| K150012 | CreoDent Solidex Customized Abutment | Jun 4, 2015 | Substantially Equivalent |
| K113738 | CREODENT SOLIDEX CUSTOM ABUTMENT | Sep 17, 2013 | Substantially Equivalent |