FDA.reportPublic FDA data

Inclusive®

Primary DI
D745701052COM00570
Brand
Inclusive®
Company
Prismatik Dentalcraft, Inc
Model
70-1052-COM0057
Catalog number
70-1052-COM0057
Device description
Inclusive® Bite Verification Cylinder, Non-Engaging compatible with: Straumann® Bone Level RC
Published
2025-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
D745701052COM00570PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis bite verification deviceA device intended to aid in the fabrication of a dental prosthesis (e.g., crown, bridge) by connecting the try-in prosthesis to the laboratory working model and to the patient for the purpose of verifying the fit and appearance of the final prosthesis before production. It is affixed with a dental prosthetic screw or dental prosthetic screw analogu(also known as guide pin). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
022761689
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701122SHS01451Obsidian70-1122-SHS014570-1122-SHS01452016-09-23
D745701182BZE05590BruxZir®70-1182-BZE055970-1182-BZE05592026-07-07
D745701182BZE05600BruxZir®70-1182-BZE056070-1182-BZE05602026-07-07
D745701182BZE05610BruxZir®70-1182-BZE056170-1182-BZE05612026-07-07
D745701182BZE05640BruxZir®70-1182-BZE056470-1182-BZE05642026-07-07
D745701182BZE05760BruxZir®70-1182-BZE057670-1182-BZE05762026-07-07
D745701182BZE05770BruxZir®70-1182-BZE057770-1182-BZE05772026-07-07
D745701182BZE05780BruxZir®70-1182-BZE057870-1182-BZE05782026-07-07
D745701182BZE05790BruxZir®70-1182-BZE057970-1182-BZE05792026-07-07
D745701182BZE05820BruxZir®70-1182-BZE058270-1182-BZE05822026-07-07
D745701182BZE05940BruxZir®70-1182-BZE059470-1182-BZE05942026-07-07
D745701182BZE05950BruxZir®70-1182-BZE059570-1182-BZE05952026-07-07
D745701182BZE05960BruxZir®70-1182-BZE059670-1182-BZE05962026-07-07
D745701182BZE05970BruxZir®70-1182-BZE059770-1182-BZE05972026-07-07
D745701182BZE06000BruxZir®70-1182-BZE060070-1182-BZE06002026-07-07
D745701182BZE06120BruxZir®70-1182-BZE061270-1182-BZE06122026-07-07
D745701182BZE06130BruxZir®70-1182-BZE061370-1182-BZE06132026-07-07
D745701182BZE06140BruxZir®70-1182-BZE061470-1182-BZE06142026-07-07
D745701182BZE06150BruxZir®70-1182-BZE061570-1182-BZE06152026-07-07
D745701182BZE06180BruxZir®70-1182-BZE061870-1182-BZE06182026-07-07

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Primary DI, Brand, Company table
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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
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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
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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
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