FDA.reportPublic FDA data

Emdogain

Primary DI
07630031700100
Brand
Emdogain
Company
Institut Straumann AG
Model
1
Catalog number
075.115
Device description
Straumann® Emdogain 0.7 ml, Enamel Matrix Derivative 30 mg/ml, contains 3 syringes Straumann® Emdogain 0.3 ml, 3 syringesStraumann® PrefGel® 0.6 ml and 6 blunt cannulas
Published
2014-09-24
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
NQABiologic Material, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQABiologic Material, DentalDental3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P930021013

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P930021013BIORA EMDOGAIN(R)The Straumann Company1996-09-30NQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031700100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031700100076300317001007630031700100

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 Volume0.7Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Protect from Sunnlight

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
483599259
Device count
1
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
07630031730022Straumann 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