FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
BTI Dental Implant System UnicCa
K Number: K173257
·
Decision Aug 17, 2018
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
15
Review Days
311
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Basic Information
- Device Name
- BTI Dental Implant System UnicCa
- K Number
- K173257
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- B.T.I. Biotechnology Institute, Sl.
- Date Received
- October 10, 2017
- Decision Date
- August 17, 2018
- Product Code
- DZE
- 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 |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | FDA class 2 | Dental |
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Other Clearances by B.T.I. Biotechnology Institute, Sl.
| K Number | Device Name | ||
|---|---|---|---|
| K240262 | BTI Interna 3.0 Dental Implant System UnicCa® | Oct 10, 2024 | Substantially Equivalent |
| K232750 | BTI Interna Prosthetic Components | Dec 8, 2023 | Substantially Equivalent |
| K231827 | BTI Dental Implant System UnicCa® Aesthetic Post Abutments | Sep 15, 2023 | Substantially Equivalent |
| K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | Oct 20, 2022 | Substantially Equivalent |
| K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | Jul 21, 2022 | Substantially Equivalent |
| K202825 | BTI Extra-Short Dental Implant System UnicCa | Jul 29, 2021 | Substantially Equivalent |
| K151391 | BTI Dental Implant System UnicCa | May 2, 2016 | Substantially Equivalent |
| K091387 | BTI DENTAL IMPLANT 5.5-6.5 | Jan 22, 2010 | Substantially Equivalent |
| K092112 | BTI DENTAL IMPLANT TINY 2.5-3.0 | Oct 6, 2009 | Substantially Equivalent |
| K070533 | BTI ENDOSSEOUS DENTAL IMPLANT ANGLED ABUTMENTS | Jun 21, 2007 | Substantially Equivalent |