Axiom

FDA UDI

Class II (US FDA UDI)

by Etablissements Anthogyr

Identity

Trade Name: Axiom FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: AXIOM IMPLANT Ø4.0 x 18.0 Replacement of a missing tooth for placement of a dental restoration FDA UDI
Model / Reference: OP40180 FDA UDI
Description: AXIOM IMPLANT Ø4.0 x 18.0 Replacement of a missing tooth for placement of a dental restoration FDA UDI

Identifiers

Primary DI / UDI-DI: 03663394000178 FDA UDI
FDA Product Code: DZE FDA UDI
GMDN Term: Screw endosteal dental implant, two-piece 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 18.0 Millimeter FDA UDI
Outer Diameter — 4.0 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

Axiom by Etablissements Anthogyr — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Etablissements Anthogyr

Sources (1)

FDA UDI ee40cd41-8546-4c77-b06b-24992da4c81e 36 fields · synced May 30, 2026