FDA.report

Inclusive®

Primary DI
D745701190COM01150
Brand
Inclusive®
Company
Prismatik Dentalcraft, Inc
Model
70-1190-COM0115
Catalog number
70-1190-COM0115
Device description
Inclusive® Titanium Screw compatible with: Implant Direct® InterActive® Ø3.4 mm
Published
2024-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NHAAbutment, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions

SubmissionSupplement
K240240000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240240000Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant SystemsPrismatik Dentalcraft, Inc.2024-07-12NHA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D745701190COM01150PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
022761689
Device count
1
DM exempt
false
Premarket exempt
false
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
true

Other Devices From This Company

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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