FDA.reportPublic FDA data

Traxodent - Itena

Primary DI
00348783001020
Brand
Traxodent - Itena
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
TRASTRT-2
Catalog number
7007097
Device description
Traxodent Trial (2 pack) - ITENA
Published
2023-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MVLCord, Retraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083695000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083695000TRAXODENTPremier Dental Products Co.2009-04-28MVL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783001020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783001020003487830010203487830010200348783001020

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction solutionA liquid substance used in dentistry to induce gingival retraction by in situ impregnation of a non-medicated gingival retraction cord. It induces contraction of the upper strata of the free gingiva typically through the action of an astringent agent (e.g., aluminium chloride). This device may also induce a local stasis of gingival exudates and gingival haemorrhages. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783008265Premier Cavity Prep10031892026-04-01
00348783008722Premier Applicators10031152026-04-01
00348783008975Premier Pluggers10038162026-04-29
00348783008982Premier Pluggers10038172026-04-29
00348783009125Premier Pluggers10038022026-04-29
00348783009507Premier Spreader10039052026-05-06
00348783009514Premier Spreader10039062026-05-06
00348783010176Premier Crown Removers10035762026-04-02
00348783009064Premier Pluggers10038812026-03-17
00348783009361Premier Burnisher10030272026-03-17
D6919053036Premier REAMERS90530362023-10-17
00348783011234Premier Jarcho Cannula10308402026-06-10
00348783011340Premier Needle Adapter10324532026-06-10
00348783011357Premier Needle Adapter10324542026-06-10
00348783011364Premier Needle Adapter10324552026-06-10
00348783011371Premier Needle Adapter10324562026-06-10
00348783011456Premier Sawyer Retractor10501052026-06-10
00348783011463Premier Sawyer Retractor10501062026-06-10
00348783012415Premier Jackson Improved Short Tracheostomy Tube81000412026-06-10
00348783015591Bond-PR30052502026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809370410059SMARTCORDEASTDENT CO., LTDMVL2026-10-01
08809370410066SMARTCORDEASTDENT CO., LTDMVL2026-10-01
08809370410073SMARTCORDEASTDENT CO., LTDMVL2026-10-01
08809370410080SMARTCORDEASTDENT CO., LTDMVL2026-10-01
08809370410097SMARTCORDEASTDENT CO., LTDMVL2026-10-01
08809370410219SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410226SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410233SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410240SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410257SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410332SMARTCORD XEASTDENT CO., LTDMVL2026-10-01
08809370410363SMARTCORDEASTDENT CO., LTDMVL2026-10-01
00883205043221ViscoStat ClearULTRADENT PRODUCTS, INC.MVL2026-08-22
00883205043238ViscoStat ClearULTRADENT PRODUCTS, INC.MVL2026-08-22
00883205043245ViscoStat ClearULTRADENT PRODUCTS, INC.MVL2026-08-22
00883205043252ViscoStat ClearULTRADENT PRODUCTS, INC.MVL2026-08-22
J014660872140Retraxil blueKulzer GmbHMVL2026-04-21
J014660872150Retraxil blueKulzer GmbHMVL2026-04-21
J014661012760Retraxil blueKulzer GmbHMVL2026-04-21
J014661012770Retraxil blueKulzer GmbHMVL2026-04-21
J014661012780Retraxil blueKulzer GmbHMVL2026-04-21
00850079280274Sure CordHexa DentalMVL2026-03-04
00008579280274sure EndoHexa DentalMVL2026-01-22
00850079280182Sure EndoHexa DentalMVL2026-01-22
00850079280199Sure EndoHexa DentalMVL2026-01-22
00850079280205Sure endoHexa DentalMVL2026-01-22
00850079280212Sure EndoHexa DentalMVL2026-01-22
00850079280229Sure endoHexa DentalMVL2026-01-22
00850079280236Sure EndoHexa DentalMVL2026-01-22
00850079280243Sure EndoHexa DentalMVL2026-01-22