DS OmniTaper

FDA UDI

Class II (US FDA UDI)

by Dentsply Implants Manufacturing GmbH

Identity

Trade Name: DS OmniTaper FDA UDI
Generic Name: Transgingival implant FDA UDI
Device Name: TiDesign EV (XL) Ø7.0 1.5mm 15° FDA UDI
Model / Reference: 68012064 FDA UDI
Description: TiDesign EV (XL) Ø7.0 1.5mm 15° FDA UDI

Identifiers

Catalog Number: 68012064 FDA UDI
Primary DI / UDI-DI: 07392532278211 FDA UDI
FDA Product Code: NHA FDA UDI
GMDN Term: Transgingival implant 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Transgingival implant

DS OmniTaper by Dentsply Implants Manufacturing 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: Dentsply Implants Manufacturing GmbH

Sources (1)

FDA UDI b84fb205-5fb7-4821-9e95-1c4bb3f24e57 34 fields · synced May 30, 2026