FDA.reportPublic FDA data

Inclusive

Primary DI
D745701072PRC00070
Brand
Inclusive
Company
Prismatik Dentalcraft, Inc
Model
70-1072-PRC0007
Catalog number
70-1072-PRC0007
Device description
Inclusive Tapered Implant Transfer Coping, Closed-Tray, 3.5 mmP x 3.5 mmD
Published
2022-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
D745701072PRC00070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)854-7256xx@xx.xx

Regulatory Flags#

DUNS number
022761689
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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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