Symbios ™

Basic Information

• Brand Name: Symbios ™
• Primary DI: EFRIUS99U000102
• Version / Model: PepGen P-15 Particulate
• Catalog Number: US99U000102
• Company Name: Dentsply Implants Manufacturing GmbH
• Labeler DUNS: 344038836
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2014-12-02
• Public Version: 3
• Public Version Date: 2023-10-13
• Public Version Status: Update
• Public Device Record Key: 5f56e794-3cb8-4bde-9557-3f33da598d0d
• Distribution End Date: 2015-11-01

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NPZ	Bone grafting material, dental, with biologic component	Dental	872.3930	3

GMDN Terms

Code	Name	Definition	Implantable	Status
47968	Dental bone matrix implant, animal-derived	A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EFRIUS99U000102	HIBCC
Unit of Use	EFRIUS99U0001022	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	1	Gram