FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇩 Andorra
Klockner Abutments
K Number: K230103
·
Decision Apr 24, 2023
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
11
Review Days
101
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Basic Information
- Device Name
- Klockner Abutments
- K Number
- K230103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SOADCO, S.L.
- Date Received
- January 13, 2023
- Decision Date
- April 24, 2023
- 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 SOADCO, S.L.
| K Number | Device Name | ||
|---|---|---|---|
| K243128 | Klockner Kits | Dec 18, 2024 | Substantially Equivalent |
| K173642 | KLOCKNER SURGICAL BOX | Oct 2, 2018 | Substantially Equivalent |
| K170022 | Klockner Vega TiBase for CEREC | Nov 16, 2017 | Substantially Equivalent |
| K153098 | KLOCKNER VEGA DENTAL IMPLANT SYSTEM | Apr 8, 2016 | Substantially Equivalent |
| K151194 | KLOCKNER DENTAL IMPLANT ABUTMENTS (II) | Jan 29, 2016 | Substantially Equivalent |
| K122988 | KLOCKNER DENTAL IMPLANT ABUTMENTS | Jul 19, 2013 | Substantially Equivalent |
| K082200 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 | Nov 25, 2008 | Substantially Equivalent |
| K080224 | KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODELS ESSENTIAL CONE (EC), ESSENTIAL SOLID (ES) AND ECK | Jul 3, 2008 | Substantially Equivalent |
| K052654 | KLOCKNER DENTAL IMPLANT, MODEL S3M | Jan 30, 2006 | Substantially Equivalent |
| K010132 | KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4 | Jun 4, 2002 | Substantially Equivalent |