FDA.reportPublic FDA data

OBS BLADE

Primary DI
04719873180509
Brand
OBS BLADE
Company
BOMEI CO., LTD.
Model
BD2907-0
Catalog number
BD2907-0
Device description
Using special gripping feature to hold screws.Material: 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
04719873180509PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719873180509047198731805094719873180509

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
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070402Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532037399Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-11-10
07392532000966Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000973Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532000997Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001529Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001604Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001765Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001772Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14