Identity
- Trade Name
- Vortex FDA UDI
- Generic Name
- Dental prosthesis/implant abutment screw analog, reusable FDA UDI
- Device Name
- Only used with LA Dental Implant Lab's Vortex™ Screw. Max angulation correction 25degrees. FDA UDI
- Model / Reference
- Ti Base FDA UDI
- Description
- Only used with LA Dental Implant Lab's Vortex™ Screw. Max angulation correction 25degrees. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011853718 FDA UDI
- 510(k) Number
- K961384 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental prosthesis/implant abutment screw analog, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental prosthesis/implant abutment screw analog, reusable
Vortex by Louisiana Dental Implant Lab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K961384 also covers:
- Vortex — LOUISIANA DENTAL IMPLANT LAB
- Vortex — LOUISIANA DENTAL IMPLANT LAB
- Vortex — LOUISIANA DENTAL IMPLANT LAB
- Vortex — LOUISIANA DENTAL IMPLANT LAB
- Vortex — LOUISIANA DENTAL IMPLANT LAB
- Sherlock — OPEN IMPLANTS
- Sherlock — OPEN IMPLANTS
- Sherlock — OPEN IMPLANTS
- Sherlock — OPEN IMPLANTS
- Sherlock — OPEN IMPLANTS
- Sherlock — OPEN IMPLANTS
- Sherlock — OPEN IMPLANTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Louisiana Dental Implant Lab
Sources (1)
- FDA UDI bee1e477-0d0c-46fb-bad3-289e0fc20e5e 34 fields · synced May 30, 2026