FDA.reportPublic FDA data

Inclusive

Primary DI
D745701073PRA00140
Brand
Inclusive
Company
Prismatik Dentalcraft, Inc
Model
70-1073-PRA0014
Catalog number
70-1073-PRA0014
Device description
Inclusive Tapered Implant Titanium Esthetic Abutment, Posterior, 4.5 mmP
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEIMPLANT, ENDOSSEOUS, ROOT-FORM
NHAAbutment, implant, dental, endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701073PRA00140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
022761689
Device count
1
DM exempt
true
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
D745701204GLG00011Glidewell™70-1204-GLG000170-1204-GLG00012026-04-15
D745701204GLG00021Glidewell™70-1204-GLG000270-1204-GLG00022026-04-15
D745701204GLG00031Glidewell™70-1204-GLG000370-1204-GLG00032026-04-15
D745701204GLG00041Glidewell™70-1204-GLG000470-1204-GLG00042026-04-15
D745701204GLG00051Glidewell™70-1204-GLG000570-1204-GLG00052026-04-15
D745701190PRA00650Glidewell HT™70-1190-PRA006570-1190-PRA00652025-03-10
D745701190PRA00660Glidewell HT™70-1190-PRA006670-1190-PRA00662025-03-10
D745701190PRA00670Glidewell HT™70-1190-PRA006770-1190-PRA00672025-03-10
D745701190PRA00680Glidewell HT™70-1190-PRA006870-1190-PRA00682025-03-10
D745701190PRA00690Glidewell HT™70-1190-PRA006970-1190-PRA00692025-03-10
D745701190PRA00010Glidewell HT™70-1190-PRA000170-1190-PRA00012024-03-21
D745701190PRA00020Glidewell HT™70-1190-PRA000270-1190-PRA00022024-03-21
D745701190PRA00030Glidewell HT™70-1190-PRA000370-1190-PRA00032024-03-21
D745701190PRA00040Glidewell HT™70-1190-PRA000470-1190-PRA00042024-03-21
D745701190PRA00050Glidewell HT™70-1190-PRA000570-1190-PRA00052024-03-21
D745701190PRA00060Glidewell HT™70-1190-PRA000670-1190-PRA00062024-03-21
D745701190PRA00070Glidewell HT™70-1190-PRA000770-1190-PRA00072024-03-21
D745701190PRA00080Glidewell HT™70-1190-PRA000870-1190-PRA00082024-03-21
D745701190PRA00090Glidewell HT™70-1190-PRA000970-1190-PRA00092024-03-21
D745701190PRA00100Glidewell HT™70-1190-PRA001070-1190-PRA00102024-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092170199PreatPreat CorporationNHA2026-06-09
00842092174999PreatPreat CorporationNHA2026-06-09
08800070229125ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229132ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229149ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229156ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229163ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229170ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229187ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229194ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229200ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229217ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229224ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229231ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229248ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229255ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229262ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229279ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229286ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229293ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229309ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229316ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229323ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
08800070229330ZENEX MULTI FixtureIzenimplant Co., Ltd.DZE2026-06-09
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04260516873086SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
04260516873093SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08
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04260516873116SIC invent Dental Implant SystemsSIC invent AGNHA2026-06-08