FDA.reportPublic FDA data

OSSIX® VOLUMAX

Primary DI
07290015477123
Brand
OSSIX® VOLUMAX
Company
DATUM DENTAL LTD
Model
OXV1525
Catalog number
100200
Device description
Resorbable collagen membrane
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K153549000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153549000OSSIX VOLUMAXDatum Dental, Ltd.2016-08-04NPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290015477123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290015477123072900154771237290015477123

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
Length0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
600170232
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290015477345OSSIX Agile™680180042023-06-05
07290015477352OSSIX Agile™680180052023-06-05
07290015477369OSSIX Agile™680180062023-06-05
07290015477376OSSIX Agile™680180072023-06-05
07290015477307OSSIX® Breeze680180042022-09-05
07290015477314OSSIX® Breeze680180052022-09-05
07290015477321OSSIX® Breeze680180062022-09-05
07290015477338OSSIX® Breeze680180072022-09-05
07290015477116OSSIX® VOLUMAXOXV10121001002016-09-01
07290015477130OSSIX® VOLUMAXOXV25301003002016-09-01
07290015477147OSSIX® VOLUMAXOXV10401004002016-09-01
07290015477215OSSIX™ Bone0.125 ccOXB01252017-08-31
07290015477222OSSIX™ Bone0.250 ccOXB02502017-08-31
07290015477253OSSIX™ Bone0.500 ccOXB05002017-08-31
07290015477710OSSIX® PLUSOXP30402015-09-27
07290015477727OSSIX® PLUSOXP25302015-09-27
07290015477765OSSIX® PLUSOXP15252015-09-27

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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