FDA.report

Inclusive

Primary DI
D745701074PRS00540
Brand
Inclusive
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
70-1074-PRS0054
Catalog number
70-1074-PRS0054
Device description
Inclusive Multi-Unit Impression Coping, Open-Tray, with Guide Pin SCS
Published
2022-12-07
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
D745701074PRS00540PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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

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08800020802910SOLO LAB ANALOGSNUCONE Co.,LTD.NDP2026-05-26
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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
08800020803061SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803078SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
08800020803085SOLO PLASTIC COPINGSNUCONE Co.,LTD.NDP2026-05-26
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