FDA.reportPublic FDA data

DIRECTscan™ Adapter Universal Kit Replacement Screw

Primary DI
05904890611887
Brand
DIRECTscan™ Adapter Universal Kit Replacement Screw
Company
APOLLO IMPLANT COMPONENTS SP Z O O
Model
DS-UniScrew
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
05904890611887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05904890611887059048906118875904890611887

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screw analog, reusableA device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a reusable 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
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
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03