FDA.reportPublic FDA data

Nylon Flat Plane Splint

Primary DI
D775JNFP0
Brand
Nylon Flat Plane Splint
Company
Great Lakes Dental Technologies, Ltd.
Model
JNFP
Published
2026-05-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D775JNFP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Regulatory Flags#

DUNS number
041854332
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D775AHAD0Hawley Retainer with Adams ClaspsAHAD2026-05-10
D775AHAR0Hawley Retainer with Arrow ClaspsAHAR2026-05-10
D775AHBC0Hawley Retainer with Ball ClaspsAHBC2026-05-10
D775AHCC0Hawley Retainer with Circumferential ClaspsAHCC2026-05-10
D775BMARPEL0MARPEBMARPEL2026-05-10
D775BMARPEP0MARPEBMARPEP2026-05-10
D775BMMT0MemotainBMMT2026-05-10
D775JFP0Splint - Flat PlaneJFP2026-05-10
D775JFPRS0Rhea Flat Plane SplintJFPRS2026-05-10
D77595102Smart Moves Complete Phase 1 Trays9512026-05-07
D775AASS0Super Spring AlignerAASS2026-05-07
D775ABLR0Bloore Removable AlignerABLR2026-05-07
D775AII0Invisible Inman AlignerAII2026-05-07
D775ALIA0Lower Inman AlignerALIA2026-05-07
D775ALIAW0Lower Inman Aligner 'Wireless' ALIAW2026-05-07
D775IBASA0Herbst -Banded Upper Or Lower-Single ArchIBASA2026-05-07
D775IBN0Bonded HerbstIBN2026-05-07
D775IBNE0Bonded Herbst - RPEIBNE2026-05-07
D775IBNER0Bonded Herbst - RPE Removable LowerIBNER2026-05-07
D775IBNR0Bonded Herbst-Removable LowerIBNR2026-05-07

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08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078338major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
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