FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
3Shape Splint Design
K Number: K191911
·
Decision Nov 27, 2019
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
33
Applicant Total
8
Review Days
133
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Basic Information
- Device Name
- 3Shape Splint Design
- K Number
- K191911
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.5470
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3Shape A/S
- Date Received
- July 17, 2019
- Decision Date
- November 27, 2019
- Product Code
- PNN
- 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 |
|---|---|---|---|
| PNN | Orthodontic Software | FDA class 2 | Dental |
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Other Clearances by 3Shape A/S
| K Number | Device Name | ||
|---|---|---|---|
| K200100 | Abutment Design | Oct 7, 2020 | Substantially Equivalent |
| K180941 | Ortho System | Oct 17, 2018 | Substantially Equivalent |
| K171634 | Ortho System | Jan 17, 2018 | Substantially Equivalent |
| K163677 | Ortho System | Apr 20, 2017 | Substantially Equivalent |
| K161884 | Ortho System | Apr 19, 2017 | Substantially Equivalent |
| K151455 | 3Shape Abutment Designer Software | Sep 6, 2016 | Substantially Equivalent |
| K152086 | 3Shape Ortho System | Apr 28, 2016 | Substantially Equivalent |