CAMLOG® SCREW-LINE Implant, Promote®

FDA UDI

Class II (US FDA UDI)

by ALTATEC GmbH

Identity

Trade Name: CAMLOG® SCREW-LINE Implant, Promote® FDA UDI
Generic Name: Screw endosteal dental implant, two-piece FDA UDI
Device Name: K1044.3313 CAMLOG® SCREW-LINE Implant, Promote® , d 3.3mm, l 13mm FDA UDI
Model / Reference: K1044.3313 FDA UDI
Description: K1044.3313 CAMLOG® SCREW-LINE Implant, Promote® , d 3.3mm, l 13mm FDA UDI

Identifiers

Catalog Number: K1044.3313 FDA UDI
Primary DI / UDI-DI: E219K104433131 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 — 3.3 Millimeter FDA UDI
Length — 13 Millimeter FDA UDI

Category: Screw endosteal dental implant, two-piece

CAMLOG® SCREW-LINE Implant, Promote® by ALTATEC GmbH — 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: ALTATEC GmbH

Sources (1)

FDA UDI cace05cf-eceb-43e1-8582-9ef10701edc9 36 fields · synced May 30, 2026