EXPASYL

Basic Information

• Brand Name: EXPASYL
• Primary DI: 03760243000775
• Version / Model: EXPASYL
• Catalog Number: 294100
• Company Name: PRODUITS DENTAIRES PIERRE ROLLAN
• Labeler DUNS: 277657631
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-20
• Public Version: 1
• Public Version Date: 2022-09-28
• Public Version Status: New
• Public Device Record Key: 47c7d23d-c18d-44c1-bb24-09ecdc62e671

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MVL	Cord, Retraction	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
16352	Gingival retraction kit	A collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760243000775	GS1

Premarket Submissions

Submission Number	Supplement Number
K050180	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius