ACTEON

Basic Information

• Brand Name: ACTEON
• Primary DI: 03760243001048
• Version / Model: EXPASYL EXACT
• Company Name: PRODUITS DENTAIRES PIERRE ROLLAN
• Labeler DUNS: 277657631
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-04
• Public Version: 1
• Public Version Date: 2020-03-12
• Public Version Status: New
• Public Device Record Key: 8f8f0617-8b14-4554-9b74-36d055756dce

Device Description

Expasyl is a paste for temporary gingival retraction that ensures separation of the marginal gingiva and drying of the sulcus

Device Characteristics

• Single Use: Yes
• 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	03760243001048	GS1
Package	03760243007170	GS1		20	In Commercial Distribution
Package	03760243007187	GS1		50	In Commercial Distribution
Package	03760243007194	GS1		5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K050180	000

Storage Conditions

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