Symbios ™ US99U000104

GUDID ERFIUS99U00014

Dentsply Implants Manufacturing GmbH

Dental bone matrix implant, animal-derived

• Primary Device ID: ERFIUS99U00014
• NIH Device Record Key: 4ba376f2-bfa3-4d2a-ac5f-b8b81d3f5df4
• Commercial Distribution Discontinuation: 2015-11-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Symbios ™
• Version Model Number: PepGen P-15 Particulate
• Catalog Number: US99U000104
• Company DUNS: 344038836
• Company Name: Dentsply Implants Manufacturing GmbH
• Device Count: 4
• DM Exempt: true
• 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: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com
• Phone: +1(800)531-3481
• Email: implants-na-cs@dentsply.com

Device Dimensions

• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ERFIUS99U00014 [Primary]
HIBCC	ERFIUS99U000144 [Unit of Use]

FDA Product Code

• NPZ: Bone grafting material, dental, with biologic component

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[ERFIUS99U00014]

Radiation Sterilization

[ERFIUS99U00014]

Radiation Sterilization

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[ERFIUS99U00014]

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[ERFIUS99U00014]

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[ERFIUS99U00014]

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[ERFIUS99U00014]

Radiation Sterilization

[ERFIUS99U00014]

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[ERFIUS99U00014]

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[ERFIUS99U00014]

Radiation Sterilization

[ERFIUS99U00014]

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[ERFIUS99U00014]

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[ERFIUS99U00014]

Radiation Sterilization

[ERFIUS99U00014]

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[ERFIUS99U00014]

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[ERFIUS99U00014]

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[ERFIUS99U00014]

Radiation Sterilization

[ERFIUS99U00014]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-12-02

On-Brand Devices [Symbios ™]

• ERFIUS99U100104: PepGen P-15 Flow
• ERFIUS99U100102: PepGen P-15 Flow
• ERFIUS99U100054: PepGen P-15 Flow
• ERFIUS99U100052: PepGen P-15 Flow
• ERFIUS99U000302: PepGen P-15 Particulate
• ERFIUS99U00014: PepGen P-15 Particulate
• ERFIUS970000304: OsteoGraf/N 700 (420–1000 microns)
• ERFIUS970000104: OsteoGraf/N 700 (420–1000 microns)
• ERFIUS930000304: OsteoGraf/N 300 (250-420 microns)
• ERFIUS930000104: OsteoGraf/N 300 (250-420 microns)
• EFRIUS99U000102: PepGen P-15 Particulate