FDA.reportPublic FDA data

OBS HANDLE / Black

Primary DI
04719873180493
Brand
OBS HANDLE / Black
Company
BOMEI CO., LTD.
Model
BD2906-0
Catalog number
BD2906-0
Device description
Operated with the shaft for screw insertion and removal.Material: AL6061/SUS304
Published
2018-02-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719873180493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873180493047198731804934719873180493

GMDN Terms#

Term, Definition table
TermDefinition
Fixture/appliance dental drill bit, reusableA shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
657693730
Device count
1
Premarket exempt
true
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
04719873180127OBS Anchorage ScrewBD-2012-0BD-2012-02016-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03
07630031778437NAInstitut Straumann AGNDP2026-06-03
07630031778444NAInstitut Straumann AGNDP2026-06-03