FDA.reportPublic FDA data

Tall Spare Parts, Straumann

Primary DI
D990TSPST0
Brand
Tall Spare Parts, Straumann
Company
SMART DENTURE CONVERSIONS, LLC
Model
TSP-ST
Published
2023-05-19
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJXAnchor, PreformedDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D990TSPST0PrimaryHIBCC0

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
8555500707contact@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
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
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EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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