FDA.reportPublic FDA data

Traxodent

Primary DI
00348783000337
Brand
Traxodent
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9007086
Device description
Unit Dose Bag Sample - 3 unit dose capsules
Published
2022-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
00348783000337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783000337003487830003373487830003370348783000337

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.

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
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
00348783015607Bond-PR30052552026-06-10
00348783015614Bond-PR30052692026-06-10
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00850079280250Sure EndoHexa DentalMVL2026-01-22
00850079280267Sure EndoHexa DentalMVL2026-01-22
00850079280281SDure endoHexa DentalMVL2026-01-22
00850079280175Sure EndoHexa DentalMVL2026-01-21
10818207024968Traxodent Gel AlCl - Bulk Syringe KitVista DentalMVL2025-06-30
10818207024975Traxodent Gel AlCl - Sample PackVista DentalMVL2025-06-30
10818207024982Traxodent Gel AlCl - Value PackVista DentalMVL2025-06-30
10818207024999Traxodent Gel AlCl - Refill KitVista DentalMVL2025-06-30
10818207025002Traxodent Gel FS - Bulk Syringe KitVista DentalMVL2025-06-30
10818207025019Traxodent Gel FS - Value PackVista DentalMVL2025-06-30
10818207025026Traxodent Gel FS - Refill KitVista DentalMVL2025-06-30
00359883005665Tissue Goo™ Hemostatic Gel 4-PackDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe KitDEN-MAT HOLDINGS, LLCMVL2025-03-18
00359883005634First String Advanced Braided Retraction Cord Non-Impregnated - SmallDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005641First String Advanced Braided Retraction Cord Non-Impregnated - MediumDEN-MAT HOLDINGS, LLCMVL2025-03-12
00359883005658First String Advanced Braided Retraction Cord Non-Impregnated - LargeDEN-MAT HOLDINGS, LLCMVL2025-03-12