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Vortex

FDA UDI

Class II (US FDA UDI)

by Louisiana Dental Implant Lab

Identity

Trade Name
Vortex FDA UDI
Generic Name
Dental prosthesis/implant abutment screw analog, reusable FDA UDI
Device Name
Dental Implant Screw FDA UDI
Model / Reference
1.4mm Screw FDA UDI
Description
Dental Implant Screw FDA UDI

Identifiers

Primary DI / UDI-DI
00198168629031 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
Not 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

Vortex by Louisiana Dental Implant Lab — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K961384 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Louisiana Dental Implant Lab

Sources (1)

  • FDA UDI ca78334e-ed42-431c-8de1-5830970a71ba 35 fields · synced May 30, 2026