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ArgenIS

FDA UDI

Class II (US FDA UDI)

by Argen Corporation, The

Identity

Trade Name
ArgenIS FDA UDI
Generic Name
Dental implant suprastructure, permanent, custom-made FDA UDI
Device Name
TiBase MA 3.0G E FDA UDI
Model / Reference
TiBase MA 3.0G E FDA UDI
Description
TiBase MA 3.0G E FDA UDI

Identifiers

Catalog Number
131710 FDA UDI
Primary DI / UDI-DI
D818131710 FDA UDI
510(k) Number
K222288 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, custom-made FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Dental implant suprastructure, permanent, custom-made

ArgenIS by Argen Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure, permanent, custom-made.

Cleared under the same submission

K222288 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argen Corporation, The

Sources (1)

  • FDA UDI 7661be67-c01b-4e23-a6ef-9ecbf5f2bc94 36 fields · synced May 30, 2026