FDA.reportPublic FDA data

GIBSON HEALTHCARE

Primary DI
00366975012425
Brand
GIBSON HEALTHCARE
Company
BENCO DENTAL SUPPLY CO.
Model
5250-917
Device description
Gibson Healthcare Seal Regenerative Collagen Dental Membrane
Published
2018-05-31
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00366975012425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00366975012425003669750124253669750124250366975012425

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
Length12Millimeter
Width16Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
570-602-6924jsoroka@benco.com

Regulatory Flags#

DUNS number
015108087
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975000880MINIBLASTER4696-3222016-09-23
00366975013347FAS-TRACT4006-9062018-12-05
00366975001887BENCO3630-3312016-09-23
D74451864890BENCO5186-4892017-11-29
D74451864980BENCO5186-4982017-11-29
D74451865230BENCO5186-5232017-11-29
D74451865320BENCO5186-5322017-11-29
D74451865410BENCO5186-5412017-11-29
00366975001894BENCO3630-3682016-09-23
00366975001900BENCO3630-3862016-09-23
00366975001917BENCO3630-4022016-09-23
00366975032768BENCO3630-0552016-09-23
00366975070005Sterling5259-5162025-02-26
00366975069993Sterling6694-6422025-02-26
00366975058768BENCO5726-5832022-08-04
00366975003317BENCO3470-4242016-09-23
00366975003409BENCO3470-4152016-09-23
D744101162914Gibson Healthcare1011-6291011-6292015-10-22
D744101164714Gibson Healthcare1011-6471011-6472015-10-22
D74417597511Gibson Healthcare175975117597512017-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09421907331614Endoform™ Dental MembraneAROA BIOSURGERY LIMITEDNPL2026-04-22
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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