FDA.reportPublic FDA data

Symbios ™

Primary DI
ERFIUS970000104
Brand
Symbios ™
Company
Dentsply Implants Manufacturing GmbH
Model
OsteoGraf/N 700 (420–1000 microns)
Catalog number
US970000104
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
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
ERFIUS970000104PrimaryHIBCC0
ERFIUS9700001044Unit 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
Weight1Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius32 Degrees Celsius

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
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07392532220166ANKYLOS®31037206310372062022-07-14
07392532218590ANKYLOS®31033370310333702025-10-17
07392532171673Astra Tech Implant System®25855258552022-11-11
07392532233661FRIOS®90-503790-50372022-07-15
07392532233678FRIOS®90-503890-50382022-07-15
07392532233920FRIADENT®91-451091-45102022-07-15
07392532066993Astra Tech Implant System®24573245732022-07-14
07392532072963Astra Tech Implant System®24801248012022-07-14
07392532151644Astra Tech Implant System®25721257212022-07-14
07392532151651Astra Tech Implant System®25722257222022-07-14
07392532151668Astra Tech Implant System®25723257232022-07-14
07392532151675Astra Tech Implant System®25769257692022-07-14
07392532169366Astra Tech Implant System®26098260982022-07-14
07392532169373Astra Tech Implant System®26099260992022-07-14
07392532218200ANKYLOS®31033030310330302022-07-14
07392532218224ANKYLOS®31033040310330402022-07-14
07392532218309ANKYLOS®31033095310330952022-07-14
07392532218606ANKYLOS®31033400310334002022-07-14
07392532219184ANKYLOS®31034350310343502022-07-14
07392532219191ANKYLOS®31034352310343522022-07-14

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
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
ERFIUS99U100054Symbios ™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