FDA.reportPublic FDA data

GEM 21S®

Primary DI
00850001118002
Brand
GEM 21S®
Company
LYNCH BIOLOGICS, LLC
Model
LBGEM05
Device description
Growth-Factor Enhanced Matrix for Periodontal Regeneration
Published
2018-10-18
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

Product Codes#

Code, Name table
CodeName
NPZBone Grafting Material, Dental, With Biologic Component
NQABiologic Material, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPZBone Grafting Material, Dental, With Biologic ComponentDental3
NQABiologic Material, DentalDental3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P040013000
P040013014
P040013015
P040013016
P040013018
P040013020

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P040013000GEM 21S (GROWTH-FACTOR ENHANCED MATRIXLynch Biologics, LLC2005-11-18NPZ
P040013014GEM 21S (GROWTH-FACTOR ENHANCED MATRIXLynch Biologics, LLC2005-11-18NPZ
P040013015GEM 21S (GROWTH-FACTOR ENHANCED MATRIXLynch Biologics, LLC2005-11-18NPZ
P040013016GEM 21S (GROWTH-FACTOR ENHANCED MATRIXLynch Biologics, LLC2005-11-18NPZ
P040013018GEM 21S (GROWTH-FACTOR ENHANCED MATRIXLynch Biologics, LLC2005-11-18NPZ
P040013020GEM 21S (GROWTH-FACTOR ENHANCED MATRIXLynch Biologics, LLC2005-11-18NPZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001118002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001118002008500011180028500011180020850001118002

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
Weight0.5Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Special Storage Condition, Specify00Do not freeze
Special Storage Condition, Specify00Protect from light

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079604282
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850001118191GEM™ Wound Dressing TapeLBWDT2018-10-18
10850001118207GEM™ Wound Dressing FoamLBWDF2018-10-18
10850001118214GEM™ Wound Dressing PlugLBWDP2018-10-18
00850001118088GEM™ Bone GraftLBNB05102018-10-18
00850001118095GEM™ Bone GraftLBNB10102018-10-18
00850001118101GEM™ Bone GraftLBNB20102018-10-18
00850001118019GEM Adapt™LBADAPT15202018-10-18
00850001118026GEM Adapt™LBADAPT20302018-10-18
00850001118033GEM Adapt™LBADAPT30402018-10-18
00850001118040GEM Extend™LBEXT15202018-10-18
00850001118057GEM Extend™LBEXT20302018-10-18
00850001118064GEM Extend™LBEXT30402018-10-18
00850001118071GEM Cap™LBCAP12162018-10-18
00850001118118GEM™ Bone GraftLBNB40102018-10-18
00850001118125GEM™ Bone GraftLBNB10202018-10-18
00850001118132GEM™ Bone GraftLBNB20202018-10-18
00850001118149GEM™ Bone GraftLBNBS0252018-10-18
00850001118156GEM™ Bone GraftLBNBS052018-10-18
00850001118163GEM™ Synthetic Bone GraftLBSB0502018-10-18
00850001118170GEM™ Synthetic Bone GraftLBSB1002018-10-18

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
EFRIUS99U000102Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS930000104Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS930000304Symbios ™Dentsply Implants Manufacturing GmbHNPZ2014-12-02
ERFIUS970000104Symbios ™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
07630031700025EmdogainInstitut Straumann AGNQA2014-09-24
07630031700087EmdogainInstitut Straumann AGNQA2014-09-24
07630031700100EmdogainInstitut Straumann AGNQA2014-09-24
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