FDA.reportPublic FDA data

EU Retrax Gel AS ProPack

Primary DI
00310866002279
Brand
EU Retrax Gel AS ProPack
Company
PASCAL COMPANY, INC.
Model
16540
Catalog number
16540
Device description
25% aluminum sulfate gel, 12 - 0.75g syringe; Green
Published
2022-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00310866002279PrimaryGS10
00310866001715Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00310866002279003108660022793108660022790310866002279
00310866001715003108660017153108660017150310866001715

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.75Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
8004268051pascal@pascaldental.com

Regulatory Flags#

DUNS number
009260217
Device count
12
Premarket exempt
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