FDA.reportPublic FDA data

Straumann Emdogain

Primary DI
07630031730022
Brand
Straumann Emdogain
Company
Institut Straumann AG
Model
Emdogain
Catalog number
075.116W
Device description
Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.7 ml (30 mg/ml), Straumann PrefGel 3 x 0.6 ml (24% EDTA)
Published
2019-03-06
Public version status
New
Distribution status
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
NQABiologic Material, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQABiologic Material, DentalDental3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P930021020

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P930021020BIORA EMDOGAIN(R)The Straumann Company1996-09-30NQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031730022PrimaryGS10
07630031747013Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031730022076300317300227630031730022
07630031747013076300317470137630031747013

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal root surface regeneration materialA bioabsorbable material intended to be used alone or in combination with bone graft materials for the regeneration of tooth support that has been lost due to periodontal disease or trauma. It is applied during periodontal flap surgery to the scaled and preconditioned root surface and forms an insoluble matrix that creates a suitable root surface for selective periodontal cell migration and cell attachment, which re-establishes the lost tooth support. It is typically presented in the form of a gel, or as a solution and enamel matrix material that is mixed into a gel prior to application. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.8Milliliter
Total Volume2.1Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit46 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 800 4488168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
3
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031778086NAsurgically Invasive Instruments066.50632026-06-03
07630031778093NAsurgically Invasive Instruments066.50642026-06-03
07630031778109NAsurgically Invasive Instruments066.50652026-06-03
07630031778116NAsurgically Invasive Instruments066.50662026-06-03
07630031778123NAsurgically Invasive Instruments066.50672026-06-03
07630031778130NAsurgically Invasive Instruments066.50682026-06-03
07630031778147NAsurgically Invasive Instruments066.50692026-06-03
07630031778154NAsurgically Invasive Instruments066.50702026-06-03
07630031778161NAsurgically Invasive Instruments066.50712026-06-03
07630031778192NAsurgically Invasive Instruments066.50742026-06-03
07630031778208NAsurgically Invasive Instruments066.50752026-06-03
07630031778215NAsurgically Invasive Instruments066.50762026-06-03
07630031778222NAsurgically Invasive Instruments066.50772026-06-03
07630031778239NAsurgically Invasive Instruments066.50782026-06-03
07630031778260NAsurgically Invasive Instruments066.50812026-06-03
07630031778277NAsurgically Invasive Instruments066.50822026-06-03
07630031778284NAsurgically Invasive Instruments066.50832026-06-03
07630031778291NAsurgically Invasive Instruments066.50842026-06-03
07630031778307NAsurgically Invasive Instruments066.50852026-06-03
07630031778338NAsurgically Invasive Instruments066.50882026-06-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630031747372Straumann EmdogainInstitut Straumann AGNQA2020-08-06
07630031747389Straumann EmdogainInstitut Straumann AGNQA2020-08-06
07630031729989Straumann EmdogainInstitut Straumann AGNQA2019-03-06
07630031730015Straumann EmdogainInstitut Straumann AGNQA2019-03-06
07630031730039Straumann EmdogainInstitut Straumann AGNQA2019-03-06
07630031730046Straumann EmdogainInstitut Straumann AGNQA2019-03-06
00850001118002GEM 21S®LYNCH BIOLOGICS, LLCNQA2018-10-18
07630031700025EmdogainInstitut Straumann AGNQA2014-09-24
07630031700087EmdogainInstitut Straumann AGNQA2014-09-24
07630031700100EmdogainInstitut Straumann AGNQA2014-09-24