FDA.reportPublic FDA data

Expasyl cannulas

Primary DI
03760243009822
Brand
Expasyl cannulas
Company
PRODUITS DENTAIRES PIERRE ROLLAN
Model
EXPASYL
Catalog number
261005
Device description
Expasyl straight application cannulas x100 for EXPASYL paste (sulcular opening paste).
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
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
03760243000737PrimaryGS10
03760243009822Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760243000720037602430007203760243000720
03760243000737037602430007373760243000737
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33556340607info@acteongroup.com
+33(0)556349292acteon-manufacturing@acteongroup.com

Regulatory Flags#

DUNS number
277657631
Device count
100
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
true
Expiration date on label
false
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
03760243009839Expasyl cannulasEXPASYL2610152022-09-20
03760243007033EXPASYL x6EXPASYL2940102022-09-20

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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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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