FDA.reportPublic FDA data

Symbios ™

Primary DI
ERFIUS99U100054
Brand
Symbios ™
Company
Dentsply Implants Manufacturing GmbH
Model
PepGen P-15 Flow
Catalog number
US99U100054
Published
2014-12-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NPZBone grafting material, dental, with biologic component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPZBone Grafting Material, Dental, With Biologic ComponentDental3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ERFIUS99U100054PrimaryHIBCC0
ERFIUS99U1000544Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bone matrix implant, animal-derivedA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)531-3481implants-na-cs@dentsply.com

Regulatory Flags#

DUNS number
344038836
Device count
4
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D716IOSCRM30400SYMBIOS®USOSCRM3040OSCRM30402017-06-24
D716OSCRM15200SYMBIOS®USOSCRM1520OSCRM15202017-06-24
D716OSCRM20300SYMBIOS®USOSCRM2030OSCRM20302017-06-24
D716OSNRM12240SYMBIOS®USOSNRM1224OSNRM12242017-06-24
D716OSNRM25300SYMBIOS®USOSNRM2530OSNRM25302017-06-24
D716OSTRNRM12200SYMBIOS®USOSTRNRM1220OSTRNRM12202017-06-24
D716OSTRNRM25300SYMBIOS®USOSTRNRM2530OSTRNRM25302017-06-24
EFRI9000001041SYMBIOS®9000001049000001042017-06-30
EFRI9000003041SYMBIOS®9000003049000003042017-06-30
EFRI9200001041SYMBIOS®9200001049200001042017-06-30
EFRI9300001041SYMBIOS®9300001049300001042017-06-30
EFRI9300003041SYMBIOS®9300003049300003042017-06-30
EFRI9400000541SYMBIOS®9400000549400000542017-06-30
EFRI9400001041SYMBIOS®9400001049400001042017-06-30
EFRI9400003041SYMBIOS®9400003049400003042017-06-30
EFRI9700001041SYMBIOS®9700001049700001042017-06-30
EFRI9700003041SYMBIOS®9700003049700003042017-06-30
EFRIOSCRM15200SYMBIOS®USOSCRM1520OSCRM15202017-02-03
EFRIOSCRM20300SYMBIOS®USOSCRM2030OSCRM20302017-02-03
EFRIOSCRM30400SYMBIOS®USOSCRM3040OSCRM30402017-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850001118002GEM 21S®LYNCH BIOLOGICS, LLCNPZ2018-10-18
EFRIUS99U000102Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS930000104Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS930000304Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS970000104Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS970000304Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS99U00014Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS99U000302Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS99U100052Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS99U100102Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS99U100104Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
00681490843782INFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.NPZ2014-09-23
00681490843805INFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.NPZ2014-09-23
00681490843812INFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.NPZ2014-09-23
00681490843829INFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.NPZ2014-09-23
00613994239518INFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.NPZ2014-09-23
00613994239525INFUSE® Bone GraftMEDTRONIC SOFAMOR DANEK, INC.NPZ2014-09-23