EXPASYL x20 261030

GUDID 03760243009808

Sulcular opening paste (x20 capsules).

PRODUITS DENTAIRES PIERRE ROLLAN

Gingival retraction kit
Primary Device ID03760243009808
NIH Device Record Key21a2ce99-2620-4309-8afd-ae1cf46b0099
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXPASYL x20
Version Model NumberEXPASYL
Catalog Number261030
Company DUNS277657631
Company NamePRODUITS DENTAIRES PIERRE ROLLAN
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com
Phone+33556340607
Emailinfo@acteongroup.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760243000706 [Primary]
GS103760243007026 [Package]
Contains: 03760243000706
Package: Box [20 Units]
In Commercial Distribution
GS103760243009808 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MVLCord, Retraction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-28
Device Publish Date2022-09-20

Devices Manufactured by PRODUITS DENTAIRES PIERRE ROLLAN

03760243000027 - ADAPTATER RISKONTROL ADEC INOX2024-03-29 The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
03760243000089 - ADAPTATER RISKONTROL DCI2024-03-29 The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
03760243000263 - ADAPTATER RISKONTROL LU INOX2024-03-29 The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
03760243000270 - ADAPTATER RISKONTROL LU NEW INOX2024-03-29 The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
03760243009853 - Art by RISKONTROL2022-09-28 Disposable single use tips for air/water syringe.
03760243009914 - Classic by RISKONTROL2022-09-28 Disposable single use tips for air/water syringe
03760243009921 - Classic by RISKONTROL2022-09-28 Disposable single use tips for air/water syringe
03760243009938 - Classic by RISKONTROL2022-09-28 Disposable single use tips for air/water syringe
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