OBS Anchorage Screw
- Primary DI
- 04719873180240
- Brand
- OBS Anchorage Screw
- Company
- BOMEI CO., LTD.
- Model
- BD-2024-0
- Catalog number
- BD-2024-0
- Device 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 holeOBS 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.
- Published
- 2016-09-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- true
- Single use
- true
Product Codes#
| Code | Name |
|---|---|
| OAT | Implant, Endosseous, Orthodontic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| OAT | Implant, Endosseous, Orthodontic | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K152297 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04719873180240 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04719873180240 | 04719873180240 | 4719873180240 |
GMDN Terms#
| Term | Definition |
|---|---|
| Orthodontic anchoring screw | A small metallic rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 657693730
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 04719873180028 | OBS Anchorage Screw | BD-2002-0 | BD-2002-0 | 2016-09-01 |
| 04719873180035 | OBS Anchorage Screw | BD-2003-0 | BD-2003-0 | 2016-09-01 |
| 04719873180042 | OBS Anchorage Screw | BD-2004-0 | BD-2004-0 | 2016-09-01 |
| 04719873180059 | OBS Anchorage Screw | BD-2005-0 | BD-2005-0 | 2016-09-01 |
| 04719873180066 | OBS Anchorage Screw | BD-2006-0 | BD-2006-0 | 2016-09-01 |
| 04719873180073 | OBS Anchorage Screw | BD-2007-0 | BD-2007-0 | 2016-09-01 |
| 04719873180080 | OBS Anchorage Screw | BD-2008-0 | BD-2008-0 | 2016-09-01 |
| 04719873180103 | OBS Anchorage Screw | BD-2010-0 | BD-2010-0 | 2016-09-01 |
| 04719873180110 | OBS Anchorage Screw | BD-2011-0 | BD-2011-0 | 2016-09-01 |
| 04719873180127 | OBS Anchorage Screw | BD-2012-0 | BD-2012-0 | 2016-09-01 |
| 04719873180134 | OBS Anchorage Screw | BD-2013-0 | BD-2013-0 | 2016-09-01 |
| 04719873180141 | OBS Anchorage Screw | BD-2014-0 | BD-2014-0 | 2016-09-01 |
| 04719873180158 | OBS Anchorage Screw | BD-2015-0 | BD-2015-0 | 2016-09-01 |
| 04719873180165 | OBS Anchorage Screw | BD-2016-0 | BD-2016-0 | 2016-09-01 |
| 04719873180189 | OBS Anchorage Screw | BD-2018-0 | BD-2018-0 | 2016-09-01 |
| 04719873180196 | OBS Anchorage Screw | BD-2019-0 | BD-2019-0 | 2016-09-01 |
| 04719873180202 | OBS Anchorage Screw | BD-2020-0 | BD-2020-0 | 2016-09-01 |
| 04719873180219 | OBS Anchorage Screw | BD-2021-0 | BD-2021-0 | 2016-09-01 |
| 04719873180226 | OBS Anchorage Screw | BD-2022-0 | BD-2022-0 | 2016-09-01 |
| 04719873180233 | OBS Anchorage Screw | BD-2023-0 | BD-2023-0 | 2016-09-01 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 04719873099689 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873099696 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873099702 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873099719 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873099757 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873099764 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873099771 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873099788 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100057 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100064 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100071 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100088 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100248 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100255 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100262 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100279 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100286 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100354 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100361 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100378 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873100385 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-15 |
| 04719873093021 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-12 |
| 04719873098736 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-12 |
| 04719873099580 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-12 |
| 04719873099597 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-12 |
| 04719873099603 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-12 |
| 04719873099610 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-12 |
| 04719873099627 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-12 |
| 04719873099634 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-12 |
| 04719873099641 | BIO-RAY A-1 Anchor Screw System | MICROWARE PRECISION CO., LTD. | OAT | 2026-05-12 |