OBS Anchorage Screw

Primary DI
04719873180127
Brand
OBS Anchorage Screw
Company
BOMEI CO., LTD.
Model
BD-2012-0
Catalog number
BD-2012-0
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 table
CodeName
OATImplant, Endosseous, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OATImplant, Endosseous, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152297000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152297000OBS Anchorage ScrewBomei Co, Ltd.2016-02-09OAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873180127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873180127047198731801274719873180127

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic anchoring screwA 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 table
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 table
Primary DIBrandModelCatalogPublished
04719873180028OBS Anchorage ScrewBD-2002-0BD-2002-02016-09-01
04719873180035OBS Anchorage ScrewBD-2003-0BD-2003-02016-09-01
04719873180042OBS Anchorage ScrewBD-2004-0BD-2004-02016-09-01
04719873180059OBS Anchorage ScrewBD-2005-0BD-2005-02016-09-01
04719873180066OBS Anchorage ScrewBD-2006-0BD-2006-02016-09-01
04719873180073OBS Anchorage ScrewBD-2007-0BD-2007-02016-09-01
04719873180080OBS Anchorage ScrewBD-2008-0BD-2008-02016-09-01
04719873180103OBS Anchorage ScrewBD-2010-0BD-2010-02016-09-01
04719873180110OBS Anchorage ScrewBD-2011-0BD-2011-02016-09-01
04719873180134OBS Anchorage ScrewBD-2013-0BD-2013-02016-09-01
04719873180141OBS Anchorage ScrewBD-2014-0BD-2014-02016-09-01
04719873180158OBS Anchorage ScrewBD-2015-0BD-2015-02016-09-01
04719873180165OBS Anchorage ScrewBD-2016-0BD-2016-02016-09-01
04719873180189OBS Anchorage ScrewBD-2018-0BD-2018-02016-09-01
04719873180196OBS Anchorage ScrewBD-2019-0BD-2019-02016-09-01
04719873180202OBS Anchorage ScrewBD-2020-0BD-2020-02016-09-01
04719873180219OBS Anchorage ScrewBD-2021-0BD-2021-02016-09-01
04719873180226OBS Anchorage ScrewBD-2022-0BD-2022-02016-09-01
04719873180233OBS Anchorage ScrewBD-2023-0BD-2023-02016-09-01
04719873180240OBS Anchorage ScrewBD-2024-0BD-2024-02016-09-01

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