SuperLine II

FDA UDI

Class II (US FDA UDI)

by Dentium Usa

Identity

Trade Name: SuperLine II FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: Endosseous dental implant FDA UDI
Model / Reference: FXS4507BC FDA UDI
Description: Endosseous dental implant FDA UDI

Identifiers

Catalog Number: FXS4507BC FDA UDI
Primary DI / UDI-DI: D755FXS4507BC0 FDA UDI
510(k) Number: K213599 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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 4.5 Millimeter FDA UDI
Length — 7 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

SuperLine II by Dentium Usa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Screw endosteal dental implant, two-piece.

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Cleared under the same submission

K213599 also covers:

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: Dentium Usa

Sources (1)

FDA UDI a570196c-781c-4c49-b2db-c2399e31bc2e 38 fields · synced May 30, 2026