FDA.reportPublic FDA data

EndoCeramic MWT 50 pack

Primary DI
10810138822699
Brand
EndoCeramic MWT 50 pack
Company
Endo Direct LLC
Model
ECMWT50
Published
2023-07-16
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
EICSyringe, Periodontic, Endodontic, Irrigating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EICSyringe, Periodontic, Endodontic, IrrigatingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810138822699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081013882269910810138822699

GMDN Terms#

Term, Definition table
TermDefinition
Root canal irrigation blunt needleA slender, hollow, tubular, metal instrument with a blunt tip designed specifically for irrigation of the root canal of a tooth during an endodontic procedure. Sometimes referred to as a root canal irrigation cannula, it is typically attached to a dental syringe (not included) filled with a root canal cleaning solution. It might be bent or straight and might have either a side vented tip or a blunt open-ended tip. This is a single-use device.

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
00840456202418JMUJMU DENTAL, INCEIC2026-07-27
00840456214527JMUJMU DENTAL, INCEIC2026-07-27
00840456214534JMUJMU DENTAL, INCEIC2026-07-27
00840456214541JMUJMU DENTAL, INCEIC2026-07-27
00840456214558JMUJMU DENTAL, INCEIC2026-07-27
00840456214565JMUJMU DENTAL, INCEIC2026-07-27
00840456214572JMUJMU DENTAL, INCEIC2026-07-27
00840456214589JMUJMU DENTAL, INCEIC2026-07-27
00840456214596JMUJMU DENTAL, INCEIC2026-07-27
G149TBSB71040TBS BASICSACME ENTERPRISE.EIC2026-05-22
00371347023466Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
00371347023473Advance Dental ProductsThe Atlanta Dental Supply CompanyEIC2026-04-14
G1493807003TBS DentalACME ENTERPRISE.EIC2026-03-02
00850014374983MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850014374990MARK3®CARGUS INTERNATIONAL, INCEIC2026-02-05
00850440008339IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008346IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008353IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008360IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008377IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008384IrriGatorEngineered Endodontics, LLCEIC2026-01-02
00850440008391ES Cap TipsEngineered Endodontics, LLCEIC2026-01-02
00850440008513ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008520ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008537ES VacEngineered Endodontics, LLCEIC2026-01-02
00850440008551JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008568JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
00850440008575JS IrriGator Engineered Endodontics, LLCEIC2026-01-02
008504400086433DPD Paste Delivery TipEngineered Endodontics, LLCEIC2026-01-02
00850440008650Capillary Tip - PremiumEngineered Endodontics, LLCEIC2026-01-02