FDA.reportPublic FDA data

ProShape Gutta Percha ISO 20.04

Primary DI
10810138822330
Brand
ProShape Gutta Percha ISO 20.04
Company
Endo Direct LLC
Model
SDPP3004
Published
2023-07-15
Public version status
Update
Distribution status
Not 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
10810138822330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081013882233010810138822330

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125216703
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810138823450ProShape Cyclone 60/06 25mmPS6006252026-05-11
10810138823429ProShape Cyclone KD File, 55/06, 21mmSamplePS5506212026-04-13
10810138823436ProShape Cyclone KD File, 60/06, 21mmSamplePS6006212026-04-13
10810138823443ProShape Cyclone KD File, 55/06, 25mmSamplePS5506252026-04-13
10810138823382ProShape HT-Assorted PackSample2026-03-16
10810138823399ProShape One Assorted PackSample2026-03-16
10810138823405Proshape Cyclone Asst PackSample2026-03-16
10810138823412Proshape Conserve Asst PackSample2026-03-16
10810138823276RC MixEDRCMIX2025-03-03
10810138823269ProShape Orifice BarrierPSOS172025-01-13
10810138823245ProShape Path Size 13 21mmPSPATH212024-11-14
10810138823252ProShape Path Size 13 25mmPSPATH252024-11-14
10810138822255ProShape One Gutta Percha SmallSDGP250612023-07-15
10810138822262ProShape One Gutta Percha PrimarySDGP300612023-07-15
10810138822279ProShape One Gutta Percha MediumSDGP350612023-07-15
10810138822286ProShape One Gutta Percha LargeSDGP400612023-07-15
10810138822293ProShape One Paper Points SmallSDGP450612023-07-15
10810138822309ProShape One Paper Points PrimarySDGP500612023-07-15
10810138822316ProShape One Paper Points MediumSDPP20042023-07-15
10810138822323ProShape One Paper Points LargeSDPP25042023-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J0030525020Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525025Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525030Z1Gutta Percha Points ISOMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525035Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525040Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525045Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525050Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525055Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525060Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525160Z1Gutta Percha pointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030525165Z1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530F1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FFZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FM1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FMZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530FZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530L1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530M1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MFZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530MZ1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530XF1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030530XFM1Gutta Percha Points GPMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FL1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FM1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541FS1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541L1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541M1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26
J0030541S1Gutta Percha PointsMAILLEFER INSTRUMENTS HOLDING SàrlEKM2026-08-26