FDA.reportPublic FDA data

STRAUMANN MEMBRAGEL

Primary DI
07630031700148
Brand
STRAUMANN MEMBRAGEL
Company
Institut Straumann AG
Model
1
Catalog number
070.101
Device description
Straumann® MembraGel® 0.8 ml
Published
2015-09-24
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
NPKBarrier, synthetic, intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPKBarrier, Synthetic, IntraoralDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082111000STRAUMANN MEMBRAGELInstitut Straumann AG2009-05-22NPK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031700148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031700148076300317001487630031700148

GMDN Terms#

Term, Definition table
TermDefinition
Hydrogel dental regeneration membraneA sterile bioabsorbable material intended to be used to aid in dental and maxillofacial bone regeneration (e.g., after periodontal disease, or after tooth loss or trauma) by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is comprised of synthetic liquid compounds that are mixed to react and form a gel (typically includes syringes and mixing tip); it is applied between soft tissue and bone during guided bone regeneration (GBR), periodontal flap surgery, and guided tissue regeneration (GTR) surgical procedures. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.8Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-8168info.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
07630031711366NAPlan Abutments025.2602-042022-12-02
07630031711410NAPlan Abutments025.2612-042022-12-02
07630031711427NAPlan Abutments025.2613-042022-12-02
07630031711465NAPlan Abutments025.2621-042022-12-02
07630031712639NATransfer aids025.4913-042022-12-02
07630031722645NAPlan Abutments048.073V42022-12-02
07630031723000NAConventional impression048.122V42022-12-02
07630031723970NAPlan Abutments048.276V42022-12-02
07630031724021NAPlan Abutments048.283V42022-12-02
07630031724038NAPlan Abutments048.284V42022-12-02
07630031724045NAPlan Abutments048.285V42022-12-02
07630031724052NAPlan Abutments048.286V42022-12-02
07630031724069NAPlan Abutments048.287V42022-12-02
07630031734884N!CE Glass Ceramic Blocks For Amann GirrbachMilling Materials010.71352023-08-24
07630031734921N!CE Glass Ceramic Blocks For Amann GirrbachMilling Materials010.71392022-04-14
07630031731012n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70522019-06-18
07630031731029n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70532019-06-18
07630031731050n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70562019-06-18
07630031731067n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70572019-06-18
07630031731081n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70592019-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841336100213Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNPK2025-11-11
08800016105865InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2025-10-14
08800039006682TBS PTFE membranePURGO BIOLOGICS Inc.NPK2025-07-24
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08800016107135InnoGenic™ Non-resorbable Membrane-InnoGenic™ Wifi-MeshCowellmedi Co.,LtdNPK2024-05-24
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08809471726370InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
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08809471726394InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
08809471726400InnoGenic™ Non-resorbable Membrane-InnoGenic™ PTFE-MeshCowellmedi Co.,LtdNPK2024-05-24
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