FDA.reportPublic FDA data

SIMDA Abutment

Primary DI
08800137712331
Brand
SIMDA Abutment
Company
SIMDA CO.,LTD.
Model
ALEV48
Catalog number
ALEV48
Device description
Lab Analog
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true

Contact Domains#

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
08800137712331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800137712331088001377123318800137712331

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, laboratoryA rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(206) 438-3441info@blacksmithwave.com

Regulatory Flags#

DUNS number
694873150
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800137711259SIMDA AbutmentTBBIH3813HTBBIH3813H2026-04-21
08800137711266SIMDA AbutmentTBBIH3815HTBBIH3815H2026-04-21
08800137711273SIMDA AbutmentTBBIH3823HTBBIH3823H2026-04-21
08800137711280SIMDA AbutmentTBBIH3825HTBBIH3825H2026-04-21
08800137711297SIMDA AbutmentTBBIH3813NTBBIH3813N2026-04-21
08800137711303SIMDA AbutmentTBBIH3815NTBBIH3815N2026-04-21
08800137711310SIMDA AbutmentTBBIH3823NTBBIH3823N2026-04-21
08800137711327SIMDA AbutmentTBBIH3825NTBBIH3825N2026-04-21
08800137711334SIMDA AbutmentTBBIH4013HTBBIH4013H2026-04-21
08800137711341SIMDA AbutmentTBBIH4015HTBBIH4015H2026-04-21
08800137711358SIMDA AbutmentTBBIH4023HTBBIH4023H2026-04-21
08800137711365SIMDA AbutmentTBBIH4025HTBBIH4025H2026-04-21
08800137711372SIMDA AbutmentTBBIH4013NTBBIH4013N2026-04-21
08800137711389SIMDA AbutmentTBBIH4015NTBBIH4015N2026-04-21
08800137711396SIMDA AbutmentTBBIH4023NTBBIH4023N2026-04-21
08800137711402SIMDA AbutmentTBBIH4025NTBBIH4025N2026-04-21
08800137711419SIMDA AbutmentTBBIH4513HTBBIH4513H2026-04-21
08800137711426SIMDA AbutmentTBBIH4515HTBBIH4515H2026-04-21
08800137711433SIMDA AbutmentTBBIH4523HTBBIH4523H2026-04-21
08800137711440SIMDA AbutmentTBBIH4525HTBBIH4525H2026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
00815967026143RodinPac-Dent, Inc.NDP2026-07-13
00815967029403RodinPac-Dent, Inc.NDP2026-07-13
06942799000004SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000035SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000042SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000073SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000080SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000110SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNDP2026-07-13
07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748061Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748078Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748085Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748092Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12