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OBS Anchorage Screw

FDA UDI

Class II (US FDA UDI)

by Bomei Co., Ltd.

Identity

Trade Name
OBS Anchorage Screw FDA UDI
Generic Name
Orthodontic anchoring screw FDA UDI
Device Name
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 fixed 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-2014-0 FDA 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 fixed 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-2014-0 FDA UDI
Primary DI / UDI-DI
04719873180141 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Orthodontic anchoring screw

OBS Anchorage Screw by Bomei Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic anchoring screw.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bomei Co., Ltd.

Sources (1)

  • FDA UDI 367c2490-6f1b-4678-b0d8-8688e60b485f 34 fields · synced May 30, 2026