FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CREOKORREKT Aligners
K Number: K211427
·
Decision Oct 13, 2022
Classifications
1
FEI Numbers
95
Registration Numbers
95
Same Product Code
143
Applicant Total
9
Review Days
524
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CREOKORREKT Aligners
- K Number
- K211427
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Creodent Prosthetics, Ltd.
- Date Received
- May 7, 2021
- Decision Date
- October 13, 2022
- Product Code
- NXC
- 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 |
|---|---|---|---|
| NXC | Aligner, Sequential | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NXC), ordered by most recent decision date.
Smylio Aligners
FDA 510(k)
FDA Class 2
·Dental
SureSmile Aligner (ASSY500020)
FDA 510(k)
FDA Class 2
·Dental
ZSmile System
FDA 510(k)
FDA Class 2
·Dental
Clear Aligner (SCF-3348)
FDA 510(k)
FDA Class 2
·Dental
Primeprint Direct Aligner
FDA 510(k)
FDA Class 2
·Dental
Invisalign® Palatal Expander System
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Creodent Prosthetics, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K220390 | CreoDent Solidex Customized Abutment and Screw | Dec 2, 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 |
| K160436 | CreoDent Solidex Custom Abutment | Sep 29, 2016 | Substantially Equivalent |
| K150012 | CreoDent Solidex Customized Abutment | Jun 4, 2015 | Substantially Equivalent |
| K113738 | CREODENT SOLIDEX CUSTOM ABUTMENT | Sep 17, 2013 | Substantially Equivalent |