FDA.reportPublic FDA data

Protaper Universal Conform Fit

Primary DI
J003PTUGPF41
Brand
Protaper Universal Conform Fit
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
PTUGPF4
Catalog number
PTUGPF4
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EKMGUTTA-PERCHA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J003PTUGPF41PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic gutta-perchaA dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00up to 86°F

Regulatory Flags#

DUNS number
480538495
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J003PTGGPAST1Protaper Gold Conform FitPTGGPASTPTGGPAST2026-05-13
J003PTGGPF11Protaper Gold Conform FitPTGGPF1PTGGPF12026-05-13
J003PTGGPF21Protaper Gold Conform FitPTGGPF2PTGGPF22026-05-13
J003PTGGPF31Protaper Gold Conform FitPTGGPF3PTGGPF32026-05-13
J003PTGGPF41Protaper Gold Conform FitPTGGPF4PTGGPF42026-05-13
J003PTGGPF51Protaper Gold Conform FitPTGGPF5PTGGPF52026-05-13
J003PTNGPX21Protaper Next Conform FitPTNGPX2PTNGPX22026-05-13
J003PTNGPX31Protaper Next Conform FitPTNGPX3PTNGPX32026-05-13
J003PTNGPX41Protaper Next Conform FitPTNGPX4PTNGPX42026-05-13
J003PTNGPX51Protaper Next Conform FitPTNGPX5PTNGPX52026-05-13
J003PTUGPAST1Protaper Universal Conform FitPTUGPASTPTUGPAST2026-05-13
J003PTUGPF11Protaper Universal Conform FitPTUGPF1PTUGPF12026-05-13
J003PTUGPF21Protaper Universal Conform FitPTUGPF2PTUGPF22026-05-13
J003PTUGPF31Protaper Universal Conform FitPTUGPF3PTUGPF32026-05-13
J003PTUGPF51Protaper Universal Conform FitPTUGPF5PTUGPF52026-05-13
J003PULGAST1Protaper Ultimate Conform FitPULGASTPULGAST2026-05-13
J003PULGF11Protaper Ultimate Conform FitPULGF1PULGF12026-05-13
J003PULGF21Protaper Ultimate Conform FitPULGF2PULGF22026-05-13
J003PULGF31Protaper Ultimate Conform FitPULGF3PULGF32026-05-13
J003PULGFX1Protaper Ultimate Conform FitPULGFXPULGFX2026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800069213302GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213319GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213326GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213333GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213340GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213357GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213364GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213371GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213388GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213395GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213401GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213418GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213425GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213432GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213449GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213456GuttaSeal ZX® Gutta Percha PointsSURE DENT CORPORATIONEKM2026-02-09
08800069213104Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213111Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213128Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069213135Edge .04 GPSURE DENT CORPORATIONEKM2025-08-14
08800069204775B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204782B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204799B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069205000B-4U Gutta Percha PointsSURE DENT CORPORATIONEKM2025-04-03
08800069204805XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204812XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204829XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204836XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204843XP-4DSURE DENT CORPORATIONEKM2025-01-07
08800069204669MinikutSURE DENT CORPORATIONEKM2023-09-06