Symbios ™ US99U000302

GUDID ERFIUS99U000302

Dentsply Implants Manufacturing GmbH

Dental bone matrix implant, animal-derived
Primary Device IDERFIUS99U000302
NIH Device Record Keyae9d760b-2722-4d38-9053-811255ef4f7b
Commercial Distribution Discontinuation2015-11-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSymbios ™
Version Model NumberPepGen P-15 Particulate
Catalog NumberUS99U000302
Company DUNS344038836
Company NameDentsply Implants Manufacturing GmbH
Device Count2
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com
Phone+1(800)531-3481
Emailimplants-na-cs@dentsply.com

Device Dimensions

Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram
Weight3 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCERFIUS99U000302 [Primary]
HIBCCERFIUS99U0003022 [Unit of Use]

FDA Product Code

NPZBone grafting material, dental, with biologic component

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


[ERFIUS99U000302]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-12-02

On-Brand Devices [Symbios ™]

ERFIUS99U100104PepGen P-15 Flow
ERFIUS99U100102PepGen P-15 Flow
ERFIUS99U100054PepGen P-15 Flow
ERFIUS99U100052PepGen P-15 Flow
ERFIUS99U000302PepGen P-15 Particulate
ERFIUS99U00014PepGen P-15 Particulate
ERFIUS970000304OsteoGraf/N 700 (420–1000 microns)
ERFIUS970000104OsteoGraf/N 700 (420–1000 microns)
ERFIUS930000304OsteoGraf/N 300 (250-420 microns)
ERFIUS930000104OsteoGraf/N 300 (250-420 microns)
EFRIUS99U000102PepGen P-15 Particulate

Trademark Results [Symbios]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYMBIOS
SYMBIOS
97323166 not registered Live/Pending
Symbios Animal Health, LLC
2022-03-21
SYMBIOS
SYMBIOS
90805129 not registered Live/Pending
Stephen S. Luther
2021-06-30
SYMBIOS
SYMBIOS
87072716 5149958 Live/Registered
Sierra Reforestation Company
2016-06-15
SYMBIOS
SYMBIOS
85453454 4377126 Live/Registered
DENTSPLY SIRONA INC.
2011-10-21
SYMBIOS
SYMBIOS
79273351 not registered Live/Pending
Symbios Orthopédie S.A.
2019-10-02
SYMBIOS
SYMBIOS
78969438 3612502 Dead/Cancelled
Symbios Medical Products, LLC
2006-09-07
SYMBIOS
SYMBIOS
75192848 2184826 Dead/Cancelled
Symbios Logic Inc.
1996-11-01
SYMBIOS
SYMBIOS
73438450 1366522 Dead/Cancelled
MEDTRONIC, INC.
1983-08-08

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