SYMBIOS®

Basic Information

• Brand Name: SYMBIOS®
• Primary DI: EFRIOSNRM25300
• Version / Model: USOSNRM2530
• Catalog Number: OSNRM2530
• Company Name: Dentsply Implants Manufacturing GmbH
• Labeler DUNS: 344038836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-03
• Public Version: 4
• Public Version Date: 2020-12-07
• Public Version Status: Update
• Public Device Record Key: 9d56eb69-4f19-4417-865a-48a2bd5f6731

Device Description

OsteoShield® PTFE Non-Resorbable Membrane (25x30mm)

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYC	Bone grafting material, synthetic	Dental	872.3930	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58502	Pliable-polymer dental regeneration membrane, bioabsorbable, ligated	A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EFRIOSNRM25301	HIBCC		4	In Commercial Distribution
Primary	EFRIOSNRM25300	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature