EXPASYL x6 294010

GUDID 03760243007033

Sulcular opening paste (x6 capsules).

PRODUITS DENTAIRES PIERRE ROLLAN

Gingival retraction kit

• Primary Device ID: 03760243007033
• NIH Device Record Key: bba98e8c-f0fb-467d-8047-3157edf550cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPASYL x6
• Version Model Number: EXPASYL
• Catalog Number: 294010
• Company DUNS: 277657631
• Company Name: PRODUITS DENTAIRES PIERRE ROLLAN
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760243005008 [Primary]
GS1	03760243007033 [Package]; Contains: 03760243005008; Package: Box [6 Units]; In Commercial Distribution
GS1	03760243009808 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050180

FDA Product Code

• MVL: Cord, Retraction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-28
• Device Publish Date: 2022-09-20

Devices Manufactured by PRODUITS DENTAIRES PIERRE ROLLAN

• 03760243000027 - ADAPTATER RISKONTROL ADEC INOX: 2024-03-29 The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
• 03760243000089 - ADAPTATER RISKONTROL DCI: 2024-03-29 The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
• 03760243000263 - ADAPTATER RISKONTROL LU INOX: 2024-03-29 The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
• 03760243000270 - ADAPTATER RISKONTROL LU NEW INOX: 2024-03-29 The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes.
• 03760243009853 - Art by RISKONTROL: 2022-09-28 Disposable single use tips for air/water syringe.
• 03760243009914 - Classic by RISKONTROL: 2022-09-28 Disposable single use tips for air/water syringe
• 03760243009921 - Classic by RISKONTROL: 2022-09-28 Disposable single use tips for air/water syringe
• 03760243009938 - Classic by RISKONTROL: 2022-09-28 Disposable single use tips for air/water syringe