FDA.reportPublic FDA data

Inclusive

Primary DI
D745701072PRC00480
Brand
Inclusive
Company
Prismatik Dentalcraft, Inc
Model
70-1072-PRC0048
Catalog number
70-1072-PRC0048
Device description
Inclusive Multi-Unit Prosthetic Screw - Unigrip Driver
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
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D745701072PRC00480PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant/prosthesis surgical procedure kitA collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes. This is a reusable 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
022761689
Device count
1
DM exempt
true
Premarket 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
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013239MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013619MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013769MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013829MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA019019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028129MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028139MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028209MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028219MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08