Symbios ™ US99U100054
GUDID ERFIUS99U100054
Dentsply Implants Manufacturing GmbH
Dental bone matrix implant, animal-derived| Primary Device ID | ERFIUS99U100054 |
| NIH Device Record Key | 3df4e5b5-e2bc-4aae-85c7-bcb3b5520dd2 |
| Commercial Distribution Discontinuation | 2015-11-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Symbios ™ |
| Version Model Number | PepGen P-15 Flow |
| Catalog Number | US99U100054 |
| 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 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com | |
| Phone | +1(800)531-3481 |
| implants-na-cs@dentsply.com |
Device Dimensions
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 32 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | ERFIUS99U100054 [Primary] |
| HIBCC | ERFIUS99U1000544 [Unit of Use] |
FDA Product Code
| NPZ | Bone grafting material, dental, with biologic component |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[ERFIUS99U100054]
Radiation Sterilization
[ERFIUS99U100054]
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[ERFIUS99U100054]
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[ERFIUS99U100054]
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[ERFIUS99U100054]
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[ERFIUS99U100054]
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[ERFIUS99U100054]
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[ERFIUS99U100054]
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[ERFIUS99U100054]
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[ERFIUS99U100054]
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[ERFIUS99U100054]
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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 |
Trademark Results [Symbios]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYMBIOS 97323166 not registered Live/Pending |
Symbios Animal Health, LLC 2022-03-21 |
 SYMBIOS 90805129 not registered Live/Pending |
Stephen S. Luther 2021-06-30 |
 SYMBIOS 87072716 5149958 Live/Registered |
Sierra Reforestation Company 2016-06-15 |
 SYMBIOS 85453454 4377126 Live/Registered |
DENTSPLY SIRONA INC. 2011-10-21 |
 SYMBIOS 79273351 not registered Live/Pending |
Symbios Orthopédie S.A. 2019-10-02 |
 SYMBIOS 78969438 3612502 Dead/Cancelled |
Symbios Medical Products, LLC 2006-09-07 |
 SYMBIOS 75192848 2184826 Dead/Cancelled |
Symbios Logic Inc. 1996-11-01 |
 SYMBIOS 73438450 1366522 Dead/Cancelled |
MEDTRONIC, INC. 1983-08-08 |
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