FDA.reportPublic FDA data

Inclusive®

Primary DI
D745701192COM00420
Brand
Inclusive®
Company
Prismatik Dentalcraft, Inc
Model
70-1192-COM0042
Catalog number
70-1192-COM0042
Device description
Inclusive® Implant Analog compatible with: Implant Direct® RePlant® Ø4.3 mm
Published
2024-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
D745701192COM00420PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant analogA device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
022761689
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D745701181MIL001610150fastdesign.io70-1181-MIL001670-1181-MIL00162026-03-16
D745701181MIL046710150fastdesign.io70-1181-MIL046770-1181-MIL04672026-03-16
D745701075ZST00760Inclusive® 70-1075-ZST007670-1075-ZST00762026-02-20
D745701161COM00010Inclusive®70-1161-COM000170-1161-COM00012025-12-01
D745701161COM00020Inclusive®70-1161-COM000270-1161-COM00022025-12-01
D745701161COM00040Inclusive®70-1161-COM000470-1161-COM00042025-12-01
D745701161COM00050Inclusive®70-1161-COM000570-1161-COM00052025-12-01
D745701161COM00060Inclusive®70-1161-COM000670-1161-COM00062025-12-01
D745701161COM00080Inclusive®70-1161-COM000870-1161-COM00082025-12-01
D745701161COM00090Inclusive®70-1161-COM000970-1161-COM00092025-12-01
D745701161COM00100Inclusive®70-1161-COM001070-1161-COM00102025-12-01
D745701161COM00120Inclusive®70-1161-COM001270-1161-COM00122025-12-01
D745701161COM00130Inclusive®70-1161-COM001370-1161-COM00132025-12-01
D745701161COM00140Inclusive®70-1161-COM001470-1161-COM00142025-12-01
D745701161COM00160Inclusive®70-1161-COM001670-1161-COM00162025-12-01
D745701161COM00170Inclusive®70-1161-COM001770-1161-COM00172025-12-01
D745701161COM00180Inclusive®70-1161-COM001870-1161-COM00182025-12-01
D745701161COM00200Inclusive®70-1161-COM002070-1161-COM00202025-12-01
D745701161COM00210Inclusive®70-1161-COM002170-1161-COM00212025-12-01
D745701161COM00220Inclusive®70-1161-COM002270-1161-COM00222025-12-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
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08800020803023SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803030SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803047SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803054SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
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08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
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