FDA.reportPublic FDA data

Expasyl cannulas

Primary DI
03760243000720
Brand
Expasyl cannulas
Company
ACTEON MANUFACTURING
Model
EXPASYL
Catalog number
261040
Device description
Expasyl straight application cannulas x40 for EXPASYL paste (sulcular opening paste).
Published
2022-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
03760243000720PrimaryGS10
03760243009822Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760243000720037602430007203760243000720
03760243009822037602430098223760243009822

GMDN Terms#

Term, Definition table
TermDefinition
Dental material injection cannula, single-useA rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients mouth. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
283473691
Device count
40
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760243000430Art by RISKONTROLRISKONTROL2017002022-09-20
03760243000492Classic by RISKONTROLRISKONTROL2016642022-09-20
03760243000508Classic by RISKONTROLRISKONTROL2016652022-09-20
03760243000515Classic by RISKONTROLRISKONTROL2016662022-09-20
03760243000522Classic by RISKONTROLRISKONTROL2016672022-09-20
03760243000539Classic by RISKONTROLRISKONTROL2016682022-09-20
03760243000546Total protec by RISKONTROLRISKONTROL2017502022-09-20
03760243000706EXPASYL x20EXPASYL2610302022-09-20
03760243000713EXPASYL strawberry flavor EXPASYL2610012022-09-20
03760243000737Expasyl cannulasEXPASYL2610052022-09-20
03760243000744Expasyl cannulasEXPASYL2610452022-09-20
03760243000751Expasyl cannulasEXPASYL2610152022-09-20
03760243001093Classic by RISKONTROLRISKONTROL2016692025-04-01
03760243005008EXPASYL x6EXPASYL2940102022-09-20
03760243000027ADAPTATER RISKONTROL ADEC INOXRISKONTROL2001952024-03-21
03760243000089ADAPTATER RISKONTROL DCIRISKONTROL2001522024-03-21
03760243000263ADAPTATER RISKONTROL LU INOXRISKONTROL2001502024-03-21
03760243000270ADAPTATER RISKONTROL LU NEW INOXRISKONTROL2001992024-03-21
03760243000553Total protec by RISKONTROLRISKONTROL2017512022-09-20
03760243000775 EXPASYLEXPASYL2941002022-09-20

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Primary DI, Brand, Company table
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J014661012780Retraxil blueKulzer GmbHMVL2026-04-21
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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
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00359883005658First String Advanced Braided Retraction Cord Non-Impregnated - LargeDEN-MAT HOLDINGS, LLCMVL2025-03-12