FDA.reportPublic FDA data

ProShape Path Size 13 25mm

Primary DI
10810138823252
Brand
ProShape Path Size 13 25mm
Company
Endo Direct LLC
Model
PSPATH25
Published
2024-11-14
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
EKSFile, Pulp Canal, Endodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810138823252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081013882325210810138823252

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, reusableA dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
125216703
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
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
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
10810138822330ProShape Gutta Percha ISO 20.04SDPP30042023-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07640452461030EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461047EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461054EdgeGlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461061EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461078EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461085EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461092EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461108EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461115EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461122EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461139EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461146EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461153EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461160EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461177EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461184EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461191EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461207EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461214EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461221EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461238EdgeOne FireFKG Dentaire SàrlEKS2026-06-03
07640452461245EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461252EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452461269EdgeOne GlidepathFKG Dentaire SàrlEKS2026-06-03
07640452462235EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462242EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462259EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462266EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462273EdgeTaperFKG Dentaire SàrlEKS2026-06-03
07640452462280EdgeTaperFKG Dentaire SàrlEKS2026-06-03