Emdogain 075.115

GUDID 07630031700100

Straumann® Emdogain 0.7 ml, Enamel Matrix Derivative 30 mg/ml, contains 3 syringes Straumann® Emdogain 0.3 ml, 3 syringes Straumann® PrefGel® 0.6 ml a

Institut Straumann AG

Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material Periodontal root surface regeneration material
Primary Device ID07630031700100
NIH Device Record Keyfb3392fe-6413-44c4-8990-c8e16fcdf538
Commercial Distribution Discontinuation2019-02-15
Commercial Distribution StatusNot in Commercial Distribution
Brand NameEmdogain
Version Model Number1
Catalog Number075.115
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count1
DM Exemptfalse
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com
Phone800 4488168
Emailinfo.usa@straumann.com

Device Dimensions

Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter
Total Volume0.7 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from Sunnlight
Handling Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031700100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQABiologic Material, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-18
Device Publish Date2014-09-24

On-Brand Devices [Emdogain]

07630031700100Straumann® Emdogain 0.7 ml, Enamel Matrix Derivative 30 mg/ml, contains 3 syringes Straumann®
07630031700087Emdogain 0.3 ml Multipack USA, contains 3 syringes Emdogain 0.3 ml, 3 syringes PrefGel 0.6 ml an
07630031700025Straumann® Emdogain 0.15 ml, Enamel Matrix Derivative 30 mg/ml, contains 5 syringes Straumann®

Trademark Results [Emdogain]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EMDOGAIN
EMDOGAIN
86691528 4901495 Live/Registered
Straumann Holding AG
2015-07-13
EMDOGAIN
EMDOGAIN
74655961 1990962 Live/Registered
BIOVENTURES BV
1995-04-04

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