FDA.reportPublic FDA data

Guttacore Endodontic obturators and size verifier

Primary DI
J003GCP030231
Brand
Guttacore Endodontic obturators and size verifier
Company
MAILLEFER INSTRUMENTS HOLDING Sàrl
Model
GCP03023
Catalog number
GCP03023
Published
2026-03-26
Public version status
Update
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
EKMGUTTA-PERCHA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J003GCP030231PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Warm-bonded endodontic obturation system obturatorA hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device.

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
J003PTUGPF41Protaper Universal Conform FitPTUGPF4PTUGPF42026-05-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800069213814Edge One R GPSURE DENT CORPORATIONEKM2026-06-22
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