FDA.reportPublic FDA data

Nexplant

Primary DI
08800024954400
Brand
Nexplant
Company
Achimhai Medical Corporation
Model
S-HFDNM Long
Catalog number
S-HFDNM Long
Device description
Hex2.1 / Handpiece / Long
Published
2020-11-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800024954400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800024954400088000249544008800024954400

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
694197900
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
08800024957579AIMGEN MAXAMA-3530AMA-3530-PA2022-07-05
08800024957586AIMGEN MAXKTA-MKTA-M-PA2022-07-05
08800024957593AIMGEN MAXATBA30ABA-3530-PA2022-07-05
08800024957609AIMGEN MAXTBD24SABD-24S-PA2022-07-05
08800024957616AIMGEN MAXTEDI20SAED-20S-PA2022-07-05
08800024957623AIMGEN MAXTEDI20LAED-20L-PA2022-07-05
08800024957630AIMGEN MAXATW-CNATW-CN-PA2022-07-05
08800024957647AIMGEN MAXKIT-MKIT-M-PA2022-07-05
08800024957654AIMGEN MAXAMS-15AMS-15-PA2022-07-05
08800024957661AIMGEN MAXAMS-25AMS-25-PA2022-07-05
08800024957678AIMGEN MAXAMS-35AMS-35-PA2022-07-05
08800024957685AIMGEN MAXKMDA351055HMDA-351055H-PA2022-07-05
08800024957692AIMGEN MAXKMDA351555HMDA-351555H-PA2022-07-05
08800024953908AIMGEN MAXATBA00ABA-3500-PA2022-04-05
08800024953915AIMGEN MAXATBA10ABA-3510-PA2022-04-05
08800024953922AIMGEN MAXATBA20ABA-3520-PA2022-04-05
08800024953939AIMGEN MAXBACABC-0-P2022-04-05
08800024953946AIMGEN MAXTBD24LABD-24L-PA2022-04-05
08800024953960AIMGEN MAXATBLAABL-00-P2022-04-05
08800024917641AIMGEN MAXATDA552570HADA-552570H-PA2022-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899878064985NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878064992NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065005NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065012NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065029NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065036NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065043NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065050NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065067NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065074NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065081NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065098NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065104NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
07899878065111NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.DZA2026-03-18
08056099233449VIVID POST DRILLBIOLOREN SRLDZA2024-03-21
07630049952607rootEX drill short shank 1,3 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952614rootEX drill short shank 1,6 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952621rootEX drill short shank 1,8 mm, pu: 6Diaswiss SADZA2023-10-02
07630049952683rootEX drill 0,8 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952690rootEX drill 1,1 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952706rootEX drill 1,3 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952713rootEX drill 1,6 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952720rootEX drill 1,8 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952782rootEX plug short 1,0 mm, pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952799rootEX plug short 1,3 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952805rootEX plug short 1,5 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952812rootEX plug short 1,8 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952829rootEX plug short 2,0 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952836rootEX plug 1,0 mm pu: 6 pcsDiaswiss SADZA2023-10-02
07630049952843rootEX plug 1,3 mm pu: 6 pcsDiaswiss SADZA2023-10-02