3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit

FDA UDI

Class II (US FDA UDI)

by 3m Company

Identity

Trade Name: 3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit FDA UDI
Generic Name: Orthodontic anchoring screw FDA UDI
Device Name: Unitek™ TAD Introductory Kit. Implants in the kit are provided sterile by irradiation and have clinically relevant sizes. The instruments in the kit need to be moist heat/steam sterilized before use. FDA UDI
Model / Reference: 504-101 FDA UDI
Description: Unitek™ TAD Introductory Kit. Implants in the kit are provided sterile by irradiation and have clinically relevant sizes. The instruments in the kit need to be moist heat/steam sterilized before use. FDA UDI

Identifiers

Catalog Number: 504-101 FDA UDI
Primary DI / UDI-DI: 00652221153586 FDA UDI
FDA Product Code: DZE 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

Yes

FDA UDI

Single Use

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Length — 10 Millimeter FDA UDI
Length — 8 Millimeter FDA UDI
Length — 6 Millimeter FDA UDI

Category: Orthodontic anchoring screw

3M™ Unitek™ Temporary Anchorage Device (TAD) TAD Introductory Kit by 3m Company — 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
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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: 3m Company

Sources (1)

FDA UDI 8e332b5a-0049-4dea-988d-184452f95a12 36 fields · synced May 30, 2026