FDA.reportPublic FDA data

THE Cover

Primary DI
08800039003759
Brand
THE Cover
Company
PURGO BIOLOGICS Inc.
Model
BP3-1530
Device description
Repair or replace bone defects around teeth, increase or reconstruct alveolar bone.THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers from penetrating the damaged area. THE Cover induces cell proliferation from the periodontal ligament and alveolar bone.
Published
2023-10-31
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

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
K230091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230091000THE CoverPurgo Biologics, Inc.2023-10-06NPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800039003759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800039003759088000390037598800039003759

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
687429456
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800039007979CYTOSHIELDCYSD-24302026-07-22
08800039007986CYTOSHIELDCYSD-2430-52026-07-22
08800039007993CYTOSHIELDCYSD-17252026-07-22
08800039008006CYTOSHIELDCYSD-1725-52026-07-22
08800039008013TBS PTFE SutureS-PTFE3022D2026-07-22
08800039008020TBS PTFE SutureS-PTFE4022D2026-07-22
08800039008037TBS PTFE SutureS-PTFE5022D2026-07-22
08800039000123THE GraftTG-AS252018-10-15
08800039000130THE GraftTG-AS052018-10-15
08800039000147THE GraftTG-AS102018-10-15
08800039000277THE GraftTG-BS252018-10-15
08800039000284THE GraftTG-BS052018-10-15
08800039000291THE GraftTG-BS102018-10-15
08800039006651TBS PTFE SuturePTFE3022 2025-07-24
08800039006668TBS PTFE SuturePTFE4022 2025-07-24
08800039006675TBS PTFE SuturePTFE5022 2025-07-24
08800039006682TBS PTFE membraneTBSRGN082025-07-24
08800039006354BiotexBT3019D2025-04-24
08800039006361BiotexBT4019D2025-04-24
08800039006378BiotexBT5019D2025-04-24

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Primary DI, Brand, Company table
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00810179632908DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
00810179632915DynaMatrixCOOK BIOTECH INCORPORATEDNPL2026-07-31
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