FDA.reportPublic FDA data

SilTrax AS Retraction Cord 8/0

Primary DI
00310866000336
Brand
SilTrax AS Retraction Cord 8/0
Company
PASCAL COMPANY, INC.
Model
07100
Catalog number
07100
Device description
Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 8/0
Published
2019-01-29
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00310866000336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00310866000336003108660003363108660003360310866000336

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction cord, medicatedA medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature37 Degrees Fahrenheit81 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009260217
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00310866000732Retrax Cord Cutter26440264402019-01-24
00310866002552KOIS KR-1 PACKER262252024-06-04
00310866002606KOIS KR-2 PACKER262262024-06-04
00310866002613KOIS KR-3 PACKER262272024-06-04
00310866002620KOIS KR-4 PACKER262282024-06-04
00310866002637KOIS KR-5 PACKER262292024-06-04
00310866002644GET SCULPTED26-31026-3102024-05-16
00310866002651Fluorilaq Salted Caramel (10mL) Tube104022024-03-28
00310866002668Fluorilaq Mint (10mL) Tube104062024-03-28
00310866002408Racord Plus Retraction Cord 7/0007797077972021-11-22
00310866002415Racord Plus Retraction Cord 8/007800078002021-11-22
00310866002422Racord Plus Retraction Cord 9/107810078102021-11-22
00310866002439Racord Plus Retraction Cord 10/207820078202021-11-22
00310866000800Retrax Pellets12400124002019-01-31
00310866000275KnitTrax Plain Retraction Cord 00007569075692019-01-29
00310866000282KnitTrax Plain Retraction Cord 0007570075702019-01-29
00310866000299KnitTrax Plain Retraction Cord 007575075752019-01-29
00310866000305KnitTrax Plain Retraction Cord 107580075802019-01-29
00310866000312KnitTrax Plain Retraction Cord 207585075852019-01-29
00310866000329SilTrax AS Retraction Cord 7/0007097070972019-01-24

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