FDA.reportPublic FDA data

DIRECTscan™ Adapter Single Wing-A

Primary DI
05904890604957
Brand
DIRECTscan™ Adapter Single Wing-A
Company
APOLLO IMPLANT COMPONENTS SP Z O O
Model
DS1000-09A
Published
2026-03-04
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
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
05904890604957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05904890604957059048906049575904890604957

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
439457408
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05904890604964DIRECTscan™ Adapter Single Wing-BDS1000-09B2026-03-04
05904890605695DIRECTscan™ Adapter Single Wing-CDS1000-09C2026-03-04
05904890605701DIRECTscan™ Adapter Single Wing-DDS1000-09D2026-03-04
05904890605725DIRECTscan™ Adapter Double Wing-EDS2000-09E2026-03-04
05904890605749DIRECTscan™ Adapter Double Wing-FDS2000-09F2026-03-04
05904890606999DIRECTscan™ Adapter Double Wing-GDS2000-09G2026-03-04
05904890607002DIRECTscan™ Adapter Double Wing-HDS2000-09H2026-03-04
05904890607019DIRECTscan™ Adapter Kit - Complete DS-Kit2026-03-04
05904890611887DIRECTscan™ Adapter Universal Kit Replacement ScrewDS-UniScrew2026-03-04
05904890610200DIRECTscan™ Adapter Replacement ScrewDS-Screw2025-12-01
05904890607026DIRECTscan™ Adapter Single Wing-ADS1000-09A2025-04-02
05904890607033DIRECTscan™ Adapter Single Wing-BDS1000-09B2025-04-02
05904890607040DIRECTscan™ Adapter Single Wing-CDS1000-09C2025-04-02
05904890607057DIRECTscan™ Adapter Single Wing-DDS1000-09D2025-04-02
05904890607064DIRECTscan™ Adapter Double Wing-EDS2000-09E2025-04-02
05904890607477DIRECTscan™ Adapter Double Wing-FDS2000-09F2025-04-02
05904890607484DIRECTscan™ Adapter Double Wing-GDS2000-09G2025-04-02
05904890607491DIRECTscan™ Adapter Double Wing-HDS2000-09H2025-04-02
05904890607507DIRECTscan™ Adapter Kit - Complete DS-Kit2025-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00815967029403RodinPac-Dent, Inc.NDP2026-07-13
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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
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07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660899Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
07290116660981Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12
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08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
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08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09