EXPASYL 294100

GUDID 03760243000775

6 capsules (sulcular opening paste) + 1 applicator + 12 application cannulas.

PRODUITS DENTAIRES PIERRE ROLLAN

Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit Gingival retraction kit

• Primary Device ID: 03760243000775
• NIH Device Record Key: 47c7d23d-c18d-44c1-bb24-09ecdc62e671
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXPASYL
• Version Model Number: EXPASYL
• Catalog Number: 294100
• Company DUNS: 277657631
• Company Name: PRODUITS DENTAIRES PIERRE ROLLAN
• Device Count: 1
• 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	03760243000775 [Primary]

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