FDA 510(k)
FDA unclassified
Substantially Equivalent
🇩🇰 Denmark
Ortho System
K Number: K161884
·
Decision Apr 19, 2017
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
70
Applicant Total
8
Review Days
282
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Basic Information
- Device Name
- Ortho System
- K Number
- K161884
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- 3Shape A/S
- Date Received
- July 11, 2016
- Decision Date
- April 19, 2017
- Product Code
- MQC
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| MQC | Mouthguard, Prescription | FDA unclassified | Unknown |
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Other Clearances by 3Shape A/S
| K Number | Device Name | ||
|---|---|---|---|
| K200100 | Abutment Design | Oct 7, 2020 | Substantially Equivalent |
| K191911 | 3Shape Splint Design | Nov 27, 2019 | 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 |
| K151455 | 3Shape Abutment Designer Software | Sep 6, 2016 | Substantially Equivalent |
| K152086 | 3Shape Ortho System | Apr 28, 2016 | Substantially Equivalent |