OBS Anchorage screw

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref BD-2110-0Model BD

by BOMEI Co., Ltd

Identity

Trade Name: OBS Anchorage screw EUDAMEDFDA UDI
Generic Name: Orthodontic anchoring screw FDA UDI
Device Name: Non Sterile Orthodontic Anchorage Screw EUDAMED
OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a stable anchorage point for the attachment of orthodontic and pre-prosthetics appliances, in order to facilitate the orthodontic movement of teeth. OBS Anchorage Screw is available in the following diameter and length. • Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm ) • Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) There are three types of OBS Anchorage Screw. • Square collar mushroom head none hole • Square collar mushroom head round hole • Square collar mushroom head slot hole OBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use. The sterilization recommendations documented in the instructions for use (IFU) are according to “AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities” have been validated. Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes. The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only. FDA UDI
Model / Reference: BD EUDAMED
BD-2110-0 EUDAMEDFDA UDI
Description: OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a stable anchorage point for the attachment of orthodontic and pre-prosthetics appliances, in order to facilitate the orthodontic movement of teeth. OBS Anchorage Screw is available in the following diameter and length. • Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm ) • Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) There are three types of OBS Anchorage Screw. • Square collar mushroom head none hole • Square collar mushroom head round hole • Square collar mushroom head slot hole OBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use. The sterilization recommendations documented in the instructions for use (IFU) are according to “AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities” have been validated. Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes. The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only. FDA UDI

Identifiers

Catalog Number: BD-2110-0 FDA UDI
Primary DI / UDI-DI: 04719873180349 EUDAMEDFDA UDI
Basic UDI-DI: B-04719873180349 EUDAMED
FDA Product Code: OAT FDA UDI
EMDN Code: Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
GMDN Term: Orthodontic anchoring screw FDA UDI

Classification

Device Class: Class IIb EUDAMED
Class II FDA UDI
Regulation Number: 872.3640 FDA UDI
Market of Registration: Spain EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

OBS Anchorage screw by Bomei Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-04719873180349	Class IIb	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIb	Pending data

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Manufacturer

Manufacturer: BOMEI Co., Ltd
EUDAMED SRN: TW-MF-000013725
Authorised Representative: Advena Limited MT-AR-000000234

Sources (2)

EUDAMED 5eea7859-6ff6-4b99-a172-e4b2a461e114 61 fields · synced Jun 1, 2026
FDA UDI d6aea008-fed8-47be-a679-ef0ff442b7d4 34 fields · synced May 30, 2026