FDA.reportPublic FDA data

STRAUMANN TIBRUSH

Primary DI
07630031726780
Brand
STRAUMANN TIBRUSH
Company
Institut Straumann AG
Model
1
Catalog number
070.005
Device description
Straumann® TiBrush, titanium, stainless steel
Published
2016-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELBSCALER, ROTARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELBScaler, RotaryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111724000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111724000STRAUMANN TIBRUSHStraumann USA2011-09-12ELB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031726780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031726780076300317267807630031726780

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant debridement brushA sterile rotary dental instrument designed for the debridement of a patient's dental implants affected by peri-implantitis, a destructive inflammatory process of the soft and hard tissues surrounding dental implants. It is a brush-like device, typically consisting of titanium bristles at the distal end of a high-grade steel shaft, that is held in a dental handpiece which provides its rotation for the mechanical removal of biofilm from the surface of the implants. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031736451Straumann BoneceramicBoneCeramic070.1982022-04-01
07630031736468Straumann BoneceramicBoneCeramic070.1992022-04-01
07630031736475Straumann BoneceramicBoneCeramic070.2002022-04-01
07630031700155STRAUMANN GRANULESBoneCeramic070.2032015-09-24
07630031700162STRAUMANN GRANULESBoneCeramic070.2042015-09-24
07630031700179STRAUMANN GRANULESBoneCeramic070.2052015-09-24
07630031739575NAAnatomic drill guides010.40212022-11-10
07630031755537CoDiagnostiXAnatomic drill guides010.40302022-04-29
07630031739933Surgical Guide - 3D Printed Model2017010.40212018-07-19
07630031764263Straumann® BLC Implants - Indication WideningSLA Roxolid BL035.8218S2023-11-04
07630031764331Straumann® BLC Implants - Indication WideningSLActive Roxolid BL035.9218S2023-11-04
07630031778086NAsurgically Invasive Instruments066.50632026-06-03
07630031778093NAsurgically Invasive Instruments066.50642026-06-03
07630031778109NAsurgically Invasive Instruments066.50652026-06-03
07630031778116NAsurgically Invasive Instruments066.50662026-06-03
07630031778123NAsurgically Invasive Instruments066.50672026-06-03
07630031778130NAsurgically Invasive Instruments066.50682026-06-03
07630031778147NAsurgically Invasive Instruments066.50692026-06-03
07630031778154NAsurgically Invasive Instruments066.50702026-06-03
07630031778161NAsurgically Invasive Instruments066.50712026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613353169275PIEZONE.M.S. Electro Medical Systems S.A.ELB2018-10-25
08809552960594TN-BrushGENOSS CO., Ltd.ELB2018-07-10
08809552960600TN-BrushGENOSS CO., Ltd.ELB2018-07-10
07613353001766PIEZONE.M.S. Electro Medical Systems S.A.ELB2016-09-01
07613353002602PIEZONE.M.S. Electro Medical Systems S.A.ELB2016-09-01
07613353002619PIEZONE.M.S. Electro Medical Systems S.A.ELB2016-09-01