FDA.reportPublic FDA data

DIRECTscan™ Adapter Single Wing-B

Primary DI
05904890604964
Brand
DIRECTscan™ Adapter Single Wing-B
Company
APOLLO IMPLANT COMPONENTS SP Z O O
Model
DS1000-09B
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
05904890604964PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05904890604964059048906049645904890604964

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
05904890604957DIRECTscan™ Adapter Single Wing-ADS1000-09A2026-03-04
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
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