FDA.reportPublic FDA data

DIRECTscan™ Adapter Single Wing-D

Primary DI
05904890607057
Brand
DIRECTscan™ Adapter Single Wing-D
Company
APOLLO IMPLANT COMPONENTS SP Z O O
Model
DS1000-09D
Published
2025-04-02
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
05904890607057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05904890607057059048906070575904890607057

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
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
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
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053071N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053088N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053095N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053101N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053118N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053125N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053132N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053149N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053156N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053163N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053248N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053293N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053347N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053354N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053361N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053415N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
07640149886726TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886733TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886757TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886764TRITRI Dental Implants Int. AGNDP2026-10-06
06009544030287N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052401N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052418N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01
06009544052425N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-01