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OBS Anchorage screw
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref BD-2118-2Model BDRef BD-2104-2Ref BD-2111-4Ref BD-2122-2Ref BD-2123-4Ref BD-2117-0Ref BD-2106-4Ref BD-2112-4Ref BD-2111-2Ref BD-2114-4Ref BD-2112-0Ref BD-2104-4Ref BD-2112-2
Identity
- Trade Name
- OBS Anchorage screw EUDAMEDFDA UDI
- Generic Name
- Orthodontic anchoring screw FDA UDI
- Device Name
- Non Sterile Orthodontic Anchorage Screw EUDAMEDOBS 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 EUDAMEDBD-2118-2 EUDAMEDBD-2104-2 EUDAMEDBD-2111-4 EUDAMEDBD-2122-2 EUDAMEDBD-2123-4 EUDAMEDBD-2117-0 EUDAMEDBD-2106-4 EUDAMEDBD-2112-4 EUDAMEDBD-2111-2 EUDAMEDBD-2114-4 EUDAMEDBD-2112-0 EUDAMEDFDA UDIBD-2104-4 EUDAMEDBD-2112-2 EUDAMED
- 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-2112-0 FDA UDI
- Primary DI / UDI-DI
- 04719873182718 EUDAMED04719873182534 EUDAMED04719873182671 EUDAMED04719873182756 EUDAMED04719873182800 EUDAMED04719873180417 EUDAMED04719873182596 EUDAMED04719873182688 EUDAMED04719873182626 EUDAMED04719873182695 EUDAMED04719873180363 EUDAMEDFDA UDI04719873182589 EUDAMED04719873182633 EUDAMED
- Basic UDI-DI
- B-04719873182718 EUDAMEDB-04719873182534 EUDAMEDB-04719873182671 EUDAMEDB-04719873182756 EUDAMEDB-04719873182800 EUDAMEDB-04719873180417 EUDAMEDB-04719873182596 EUDAMEDB-04719873182688 EUDAMEDB-04719873182626 EUDAMEDB-04719873182695 EUDAMEDB-04719873180363 EUDAMEDB-04719873182589 EUDAMEDB-04719873182633 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
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-04719873182718 | 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 (14)
- EUDAMED 1909902e-ed85-4cc6-a92a-d605498756a6 61 fields · synced Oct 6, 2026
- EUDAMED f9c59baf-009c-4242-825b-0d175d7af84e 61 fields · synced May 16, 2026
- EUDAMED 51c1344f-1f2a-4706-892f-61061234170a 61 fields · synced May 16, 2026
- EUDAMED 1d13cc5e-6e40-4af3-a035-ac47883bdfe2 61 fields · synced May 16, 2026
- EUDAMED 0ad93580-77c5-4eda-a651-43c3727b4423 61 fields · synced May 17, 2026
- EUDAMED 6833cfd3-36a5-4225-93dc-f246cf093be7 61 fields · synced May 17, 2026
- EUDAMED 9d7e9884-3463-4caa-a507-56df524f7110 61 fields · synced May 17, 2026
- EUDAMED e66b00b4-ee12-4c3a-a3a4-d0a1475b9093 61 fields · synced May 18, 2026
- EUDAMED 51774392-ff85-4c37-af71-08a733269032 61 fields · synced May 18, 2026
- EUDAMED 635e6883-01d9-4f68-9021-3b6c3b290216 61 fields · synced May 18, 2026
- FDA UDI 35297a35-9d37-4049-8137-fcd4ea39c92c 34 fields · synced May 30, 2026
- EUDAMED d6e720d4-1131-4d0c-8e0f-2b1a588c7a4d 61 fields · synced Jul 9, 2026
- EUDAMED 89c06a57-e7fc-4dca-9637-6bac6ab02e29 61 fields · synced Jul 20, 2026
- EUDAMED f5e56f55-8718-4def-beda-ebb185218c46 61 fields · synced Jul 26, 2026