FDA.report

Inclusive

Primary DI
D745701147COM00940
Brand
Inclusive
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
70-1147-COM0094
Catalog number
70-1147-COM0094
Device description
Inclusive Guide Pin compatible with: Hiossen HG System Mini
Published
2021-08-13
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

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D745701147COM00940PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
+1(800)854-7256xx@xx.xx

Regulatory Flags

DUNS number
021228671
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 DIBrandModelCatalogPublished
D7457025AM0BruxZir70-25AM70-25AM2023-08-11
D74570BZDC0BruxZir70-BZDC70-BZDC2023-08-10
D745701026CAP00091Metal Quadrant Impression Trays70-1026-CAP000970-1026-CAP00092023-07-05
D745701026CAP00101Metal Quadrant Impression Trays70-1026-CAP001070-1026-CAP00102023-07-05
D745701123BRX00250BruxZir™ TintEFX Coloring Liquid70-1123-BRX002570-1123-BRX00252023-06-23
D745701123BRX00260BruxZir™ TintEFX Coloring Liquid70-1123-BRX002670-1123-BRX00262023-06-23
D745701123BRX00270BruxZir™ TintEFX Coloring Liquid70-1123-BRX002770-1123-BRX00272023-06-23
D745701123BRX00280BruxZir™ TintEFX Coloring Liquid70-1123-BRX002870-1123-BRX00282023-06-23
D745701123BRX00290BruxZir™ TintEFX Coloring Liquid70-1123-BRX002970-1123-BRX00292023-06-23
D745701123BRX00300BruxZir™ TintEFX Coloring Liquid70-1123-BRX003070-1123-BRX00302023-06-23
D745701123BRX00340BruxZir™ TintEFX Coloring Liquid70-1123-BRX003470-1123-BRX00342023-06-23
D745701123BRX00350BruxZir™ TintEFX Coloring Liquid70-1123-BRX003570-1123-BRX00352023-06-23
D745701123BRX00360BruxZir™ TintEFX Coloring Liquid70-1123-BRX003670-1123-BRX00362023-06-23
D745701123BRX00370BruxZir™ TintEFX Coloring Liquid70-1123-BRX003770-1123-BRX00372023-06-23
D745701123BRX00380BruxZir™ TintEFX Coloring Liquid70-1123-BRX003870-1123-BRX00382023-06-23
D745701123BRX00390BruxZir™ TintEFX Coloring Liquid70-1123-BRX003970-1123-BRX00392023-06-23
D745701123BRX00400BruxZir™ TintEFX Coloring Liquid70-1123-BRX004070-1123-BRX00402023-06-23
D745701123BRX00410BruxZir™ TintEFX Coloring Liquid70-1123-BRX004170-1123-BRX00412023-06-23
D745701185BXP05710BruxZir70-1185-BXP057170-1185-BXP05712023-06-12
D745701185BXP05720BruxZir70-1185-BXP057270-1185-BXP05722023-06-12

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800020802767ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802774ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802781ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802798ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802804ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802811ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802828ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802835ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802842ABIDING SOLO IMPRESSION CAPSNUCONE Co.,LTD.NDP2026-05-26
08800020802859SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802866SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802873SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802880SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802897SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802903SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802927SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802934SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020802996SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803009SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803016SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
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
08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020858948ABIDING MU LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
08800020859372ABIDING COUPLE DIGITAL LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26