FDA.reportPublic FDA data

TN-Brush

Primary DI
08809552960600
Brand
TN-Brush
Company
GENOSS CO., Ltd.
Model
TN-1.0
Catalog number
TN-1.0
Device description
DENTAL SCALER, ROTARY
Published
2018-07-10
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

Product Codes#

Code, Name table
CodeName
ELBSCALER, ROTARY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELBScaler, RotaryDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170596000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170596000TN-BrushGenoss Co., Ltd.2017-09-11ELB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809552960600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809552960600088095529606008809552960600

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleaning brushA hand-held instrument with bristles intended to be used to manually clean dentures. It is intended for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length3.5Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
690083006
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800026544722Implant Guide Kit GIGK2024-07-19
08800026544739Implant Guide Kit GGD26292024-07-19
08800026544746Implant Guide Kit GGD26352024-07-19
08800026544753Implant Guide Kit GMG22024-07-19
08800026544760Implant Guide Kit GSP052024-07-19
08800026544777Implant Guide Kit GSP072024-07-19
08800026544784Implant Guide Kit GSP092024-07-19
08800026544791Implant Guide Kit GSP112024-07-19
08800026544807Implant Guide Kit GGP04052024-07-19
08800026544814Implant Guide Kit GGP06072024-07-19
08800026544821Implant Guide Kit GGP08092024-07-19
08800026544838Implant Guide Kit GGP10112024-07-19
08800026501558GENOSS Inflator B30GBI-B302024-06-18
08800026501565GENOSS Inflator B30GBI-302024-06-18
08800026507598GENOSS Inflator B30GBI-B30S2024-06-18
08800026507611GENOSS Inflator B40 GBI-B40V2024-06-18
08800026507635GENOSS Inflator B40 GBI-B40VS2024-06-18
08800026512752GENOSS Inflator B40 GBI-B40S2024-06-18
08800026530329GENOSS Inflator B30GBI-B302024-06-18
08809324765433GENOSS Inflator B30GBI-30V2024-06-18

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
07630031726780STRAUMANN TIBRUSHInstitut Straumann AGELB2016-10-20
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