FDA.reportPublic FDA data

Inclusive

Primary DI
D745701052COM00880
Brand
Inclusive
Company
James R. Glidewell, Dental Ceramics, Inc.
Model
70-1052-COM0088
Catalog number
70-1052-COM0088
Device description
Inclusive Prosthetic Screw SCS
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701052COM00880PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(949)251-1269Marilyn.Pourazar@glidewelldental.com

Regulatory Flags#

DUNS number
021228671
Device count
1
DM exempt
true
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840481135989LOCATORZest Anchors, LLCDZE2026-05-22
00840481135996LOCATORZest Anchors, LLCDZE2026-05-22
00840481136009LOCATORZest Anchors, LLCDZE2026-05-22
08806395269907ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269914ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269921ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269938ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269945ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269952ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269969ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269976ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269983ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269990ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270002ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
088000968507858plant Implant System8dent Inc.DZE2026-03-24
088000968507928plant Implant System8dent Inc.DZE2026-03-24
088000968507788plant Implant System8dent Inc.DZE2026-03-23
08800362100002DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100019DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100026DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100033DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100040DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100057DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100064DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100071DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20