FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LOCATOR Angled Abutment (Various)
K Number: K233587
·
Decision Jun 3, 2024
Classifications
1
FEI Numbers
382
Registration Numbers
382
Same Product Code
708
Applicant Total
12
Review Days
208
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Basic Information
- Device Name
- LOCATOR Angled Abutment (Various)
- K Number
- K233587
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3630
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zest Anchors, LLC
- Date Received
- November 8, 2023
- Decision Date
- June 3, 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 Zest Anchors, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K260555 | LOCATOR® Angled Abutment | Apr 9, 2026 | Substantially Equivalent |
| K252944 | LOCATOR® Angled Abutment | Oct 15, 2025 | Substantially Equivalent |
| K250721 | LOCATOR® Angled Abutment | Aug 20, 2025 | Substantially Equivalent |
| K243272 | LOCATOR Angled Abutment | Jan 14, 2025 | Substantially Equivalent |
| K220252 | High Retention Attachment System | Apr 14, 2022 | Substantially Equivalent |
| K213391 | High Retention Attachment System | Jan 11, 2022 | Substantially Equivalent |
| K191619 | TurboTemp EZ | Sep 11, 2019 | Substantially Equivalent |
| K151789 | LOCATOR F-Tx Attachment System | Mar 4, 2016 | Substantially Equivalent |
| K133327 | SATURNO(TM) OVERDENTURE IMPLANT SYSTEM | Jun 25, 2014 | Substantially Equivalent |
| K140570 | CHAIRSIDE ATTACHMENT PROCESSING MATERIAL | Jun 16, 2014 | Substantially Equivalent |