FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment
K Number: K240531
·
Decision Jul 30, 2024
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
40
Review Days
158
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Basic Information
- Device Name
- SmartShape Healing Abutment; Wide Custom Milled Ti-Blank Abutment
- K Number
- K240531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BioHorizons Implant Systems, Inc.
- Date Received
- February 23, 2024
- Decision Date
- July 30, 2024
- 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 BioHorizons Implant Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243521 | Conical Ti Base abutments | May 1, 2025 | Substantially Equivalent |
| K240187 | Tapered Pro Conical Implant System | Jun 5, 2024 | Substantially Equivalent |
| K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | Oct 13, 2023 | Substantially Equivalent |
| K203252 | Multi-unit Abutments for CONELOG | Mar 16, 2021 | Substantially Equivalent |
| K182070 | BioHorizons Tapered IM Implants | Oct 10, 2018 | Substantially Equivalent |
| K180998 | BioHorizons CAD/CAM Bars | Sep 28, 2018 | Substantially Equivalent |
| K172576 | BioHorizons Tapered Short Implants | Nov 22, 2017 | Substantially Equivalent |
| K151621 | BioHorizons CAD/CAM Abutments | Jan 13, 2016 | Substantially Equivalent |
| K143022 | BioHorizons Tapered Internal Implants | Jan 8, 2015 | Substantially Equivalent |
| K121787 | BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS | Sep 5, 2012 | Substantially Equivalent |