FDA.reportPublic FDA data

Standard TiBase 10PK, Paltop (IHex)

Primary DI
D990KDIHSTB10PK0
Brand
Standard TiBase 10PK, Paltop (IHex)
Company
SMART DENTURE CONVERSIONS, LLC
Model
KDIH-STB10PK
Published
2022-12-26
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
EJXAnchor, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJXAnchor, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D990KDIHSTB10PK0PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
855-550-0707Contact@SmartDentureConversions.com

Regulatory Flags#

DUNS number
010613514
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D990SADCK1PK0Single Arch Dam Conversion Kit 1PKSADCK1PK2025-06-30
D990AD0Access Drill 1PKAD2022-12-26
D990BHHDPS10PK0Prosthetic Screw 10PK, BioHorizonsBHHD-PS10PK2022-12-26
D990BHHDPSK0Premium Starter Kit, BioHorizonsBHHD-PSK2022-12-26
D990BHHDRK0Recharge Kit, BioHorizonsBHHD-RK2022-12-26
D990BHHDSFA10PKDK0Separable Fastener Assembly 10PK w Drill Kit, BioHorizonsBHHD-SFA10PKDK2022-12-26
D990BHHDSK0Starter Kit, BioHorizonsBHHD-SK2022-12-26
D990CM10PK0Coating Mandrel 10PKCM10PK2022-12-26
D990CM6PK0Coating Mandrel 6PKCM6PK2022-12-26
D990COD0Clean Out Drill 1PKCOD2022-12-26
D990DK0Drill Kit 1PKDK2022-12-26
D990KDIHCM10PK0Coating Mandrel 10 Pack, Paltop (IHEX)KDIH-CM10PK2022-12-26
D990KDIHCM6PK0Coating Mandrel 6PK, Paltop (IHex)KDIH-CM6PK2022-12-26
D990KDIHLA10PK0Lab Analog 10PK, Paltop (IHex)KDIH-LA10PK2022-12-26
D990KDIHLTD0Torque Driver 1PK, Paltop (IHex)KDIH-LTD2022-12-26
D990KDIHPS10PK0Prosthetic Screw 10PK, Paltop (IHex)KDIH-PS10PK2022-12-26
D990KDIHPSK0Premium Starter Kit, Paltop (IHex)KDIH-PSK2022-12-26
D990KDIHRK0Recharge Kit, Paltop (IHex)KDIH-RK2022-12-26
D990KDIHSFA10PKDK0Separable Fastener Assembly 10PK - Drill Kit Included, Paltop (IHex)KDIH-SFA10PKDK2022-12-26
D990KDIHSK0Starter Kit, Paltop (IHex)KDIH-SK2022-12-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640239932098Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
07640239932104Dalbo®-PLUSCendres+Métaux SAEJX2026-02-16
08059224207810OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224208169OT EQUATOR-EASY FIXRHEIN 83 SRLEJX2026-02-10
08059224001661OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224108865OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224136905OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165189OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165196OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224165202OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224166117OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168135OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168173OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224168180OT EQUATORRHEIN 83 SRLEJX2025-07-07
08059224169910OT EQUATORRHEIN 83 SRLEJX2025-07-07
D990CTB1PK0Cementable TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PK0Pre-Coated TiBase 10PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKEX0Pre-Coated TiBase 10PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKIT0Pre-Coated TiBase 10PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB10PKOA0Pre-Coated TiBase 10PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PK0Pre-Coated TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKEX0Pre-Coated TiBase 1PK, Ext. ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKIT0Pre-Coated TiBase 1PK, Integrated ThreadSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990PTB1PKOA0Pre-Coated TiBase 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKOA0Recharge Kit w/ Tall Spare Parts, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990RKPOCOA0Recharge Kit w/ POC, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990SFA10PKDKOA0Separable Fastener Assembly 10PK - Drill Kit Included, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990STB1PK0Standard TiBase 1PKSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990STB1PKOA0Standard TiBase 1PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19
D990TC10PKOA0Temporary Cylinder 10PK, OmnibutSMART DENTURE CONVERSIONS, LLCEJX2025-05-19