FDA.reportPublic FDA data

Kontour Matrix

Primary DI
04250830900643
Brand
Kontour Matrix
Company
Matricel GmbH
Model
KMAX3040
Device description
Collagen membrane
Published
2022-01-31
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
NPLBarrier, Animal Source, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPLBarrier, Animal Source, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123697000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123697000MATRICEL DENTAL BARRIER MEMBRANEMatricel GmbH2014-02-24NPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250830900643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250830900643042508309006434250830900643

GMDN Terms#

Term, Definition table
TermDefinition
Collagen dental regeneration membraneA sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area1200Square millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49240756440info@matricel.com

Regulatory Flags#

DUNS number
344166512
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250830900803ZmatrixZM15202023-05-22
04250830900810ZmatrixZM25302023-05-22
04250830900827ZmatrixZM30402023-05-22
04250830900629Kontour MatrixKMAX15202022-01-31
04250830900636Kontour MatrixKMAX25302022-01-31
04250830900056creos™ xenoprotectN15202015-08-31
04250830900063creos™ xenoprotectN25302015-08-31
04250830900070creos™ xenoprotectN30402015-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09421907331621Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331638Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331652Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331706Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331713Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331720Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331744Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331799Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331805Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331812Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
09421907331836Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
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