FDA.reportPublic FDA data

EXPASYL x6

Primary DI
03760243007033
Brand
EXPASYL x6
Company
PRODUITS DENTAIRES PIERRE ROLLAN
Model
EXPASYL
Catalog number
294010
Device description
Sulcular opening paste (x6 capsules).
Published
2022-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MVLCord, Retraction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVLCord, RetractionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050180000EXPA-SYLProduits Dentaires Pierre Rolland2005-02-11MVL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760243007033PackageGS16In Commercial Distribution
03760243005008PrimaryGS10
03760243009808Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760243007033037602430070333760243007033
03760243005008037602430050083760243005008
03760243009808037602430098083760243009808

GMDN Terms#

Term, Definition table
TermDefinition
Gingival retraction kitA collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33(0)556349292acteon-manufacturing@acteongroup.com

Regulatory Flags#

DUNS number
277657631
Device count
6
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760243009907Classic by RISKONTROLRISKONTROL2016692025-04-01
03760243009853Art by RISKONTROLRISKONTROL2017002022-09-20
03760243009914Classic by RISKONTROLRISKONTROL2016642022-09-20
03760243009921Classic by RISKONTROLRISKONTROL2016652022-09-20
03760243009938Classic by RISKONTROLRISKONTROL2016662022-09-20
03760243009945Classic by RISKONTROLRISKONTROL2016672022-09-20
03760243009952Classic by RISKONTROLRISKONTROL2016682022-09-20
03760243009969Total protec by RISKONTROLRISKONTROL2017502022-09-20
03760243009808EXPASYL x20EXPASYL2610302022-09-20
03760243007040EXPASYL strawberry flavor EXPASYL2610012022-09-20
03760243009822Expasyl cannulasEXPASYL2610052022-09-20
03760243009839Expasyl cannulasEXPASYL2610152022-09-20

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