FDA.reportPublic FDA data

Fiber-bond 2x5ml

Primary DI
E29965251
Brand
Fiber-bond 2x5ml
Company
Polydentia SA
Model
6525
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K962374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962374000FIBER-SPLINT ML MULTILAYERPolydentia USA1996-07-22EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E29965251PrimaryHIBCC0
E29965250Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481461598
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E2995300200stop card5300205300202025-11-24
E2995300300stop card5300305300302025-11-24
E2995300400stop card5300405300402025-11-24
E2995300500stop card5300505300502025-11-24
E2995300600stop card5300605300602025-11-24
E2995300700stop card5300705300702025-11-24
E2995300800stop card5300805300802025-11-24
E29954050Cotton Roll Holder540554052025-11-24
E2995300209stop card5300205300202025-11-24
E2995300309stop card5300305300302025-11-24
E2995300409stop card5300405300402025-11-24
E2995300509stop card5300505300502025-11-24
E2995300609stop card5300605300602025-11-24
E2995300709stop card5300705300702025-11-24
E2995300809stop card5300805300802025-11-24
E29954059Cotton Roll Holder540554052025-11-24
E29912010Unica proximal120112012025-10-31
E29912019Unica proximal120112012025-10-31
E29968910myRing Prime689168912025-06-16
E29950020wood wedges500250022025-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078338major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078352major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078376major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078802major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078819major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078826major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078833major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078840major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640080751major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08720604634235Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
08720604634242Vertex-Dental BVVertex-Dental B.V.EBI2026-09-24
06971437943618UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943625UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943649UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943700UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
06971437943748UltraPrint Flexible Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-08-27
08685313736208DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736215DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
08685313736222DentaFab3BFAB TEKNOLOJI ANONIM SIRKETIEBI2026-08-25
00883205041883UltraCemULTRADENT PRODUCTS, INC.EBI2026-08-22
07630813462523XPLEX BaseCandulor AGEBI2026-07-28
00850061175175Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175182Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
00850061175199Denture Base Resin V2FORMLABS OHIO INC.EBI2026-07-21
07615208585728Ivotion BaseIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585735IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585742IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585759IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08