FDA.reportPublic FDA data

Inclusive®

Primary DI
D745701161COM00290
Brand
Inclusive®
Company
Prismatik Dentalcraft, Inc
Model
70-1161-COM0029
Catalog number
70-1161-COM0029
Device description
Inclusive® Titanium Screw compatible with: CONELOG® Ø3.3/3.8/4.3 mm
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHAAbutment, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252582000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252582000Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant SystemsPrismatik Dentalcraft, Inc.2025-11-18NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701161COM00290PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)402-1725GLDirect.Mail@glidewelldental.com

Regulatory Flags#

DUNS number
022761689
Device count
1
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
D745701122OMB01611Obsidian70-1122-OMB016170-1122-OMB01612016-09-23
D74570BIOBGP050Newport Biologics Bone Graft Putty Mineral Collagen Composite70-BIO-BGP0570-BIO-BGP052016-09-24
D74570BIOBGP100Newport Biologics Bone Graft Putty Mineral Collagen Composite70-BIO-BGP1070-BIO-BGP102016-10-07
D74570BIOBGP200Newport Biologics Bone Graft Putty Mineral Collagen Composite70-BIO-BGP2070-BIO-BGP202016-09-24
D745SN3D0Silent Nite 3D Sleep ApplianceSN3DSN3D2026-10-07
D745MAPCSDLA0Silent Nite 3D Sleep ApplianceMA-PC-SD-LAMA-PC-SD-LA2024-04-15
D745MAPCSDOP0Silent Nite 3D Sleep ApplianceMA-PC-SD-OPMA-PC-SD-OP2024-04-15
D745MAPCSDUA0Silent Nite 3D Sleep ApplianceMA-PC-SD-UAMA-PC-SD-UA2024-04-15
D745701181MIL001610150fastdesign.io70-1181-MIL001670-1181-MIL00162026-03-16
D745701181MIL046710150fastdesign.io70-1181-MIL046770-1181-MIL04672026-03-16
D745701072PRC00010Inclusive70-1072-PRC000170-1072-PRC00012015-10-24
D745701072PRC00580Inclusive70-1072-PRC005870-1072-PRC00582015-10-24
D745701173COM00040Inclusive70-1173-COM000470-1173-COM00042016-10-07
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

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Primary DI, Brand, Company table
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088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20
088000968621778plant Implant System8dent Inc.NHA2026-10-20
088000968642878plant Implant System8dent Inc.NHA2026-10-20
088000968645778plant Implant System8dent Inc.NHA2026-10-20
088000968782398plant Implant System8dent Inc.NHA2026-10-20
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