tomas®

FDA UDI

Class II (US FDA UDI)

by Dentaurum

Identity

Trade Name: tomas® FDA UDI
Generic Name: Orthodontic anchoring screw FDA UDI
Device Name: tomas® anchorage system: tomas®-pin SD N 10 (non-sterile) Length 10 mm/ sterilizable/ Core ø1.2 mm/ For further information please visit our online-shop on www.dentaurum.de FDA UDI
Model / Reference: 302-110-30 FDA UDI
Description: tomas® anchorage system: tomas®-pin SD N 10 (non-sterile) Length 10 mm/ sterilizable/ Core ø1.2 mm/ For further information please visit our online-shop on www.dentaurum.de FDA UDI

Identifiers

Primary DI / UDI-DI: J011302110300 FDA UDI
FDA Product Code: OAT FDA UDI
GMDN Term: Orthodontic anchoring screw 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthodontic anchoring screw

tomas® by Dentaurum — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic anchoring screw.

Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
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Absoanchor Microimplant — DENTOS Inc. · Class II
GBR System Bone Screw — Jeil Medical Corporation · Class II
Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II
Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class II
Dual Top Screw System / Dual Top Anchor System — Jeil Medical Corporation · Class II

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: Dentaurum

Sources (1)

FDA UDI 1016f09b-6aa4-47ce-bad0-7bfc32f28550 35 fields · synced May 30, 2026