FDA.report

ProShape K Files Size 40 31MM

Primary DI
10810138821968
Brand
ProShape K Files Size 40 31MM
Company
Endo Direct LLC
Model
KF4031
Published
2023-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EKSFile, Pulp Canal, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKSFile, Pulp Canal, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810138821968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1081013882196810810138821968

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
125216703
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10810138822767ProShape Gutta Percha F4PSGPF42024-08-02
10810138822774ProShape Gutta Percha F5PSGPF52024-08-02
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10810138822798ProShape Paper Points F2PSPPF22024-08-02
10810138822804ProShape Paper Points F3PSPPF32024-08-02
10810138822811ProShape Paper Points F4PSPPF42024-08-02
10810138822828ProShape Paper Points F5PSPPF52024-08-02
10810138822835ProShape One Gutta Percha SmallPSOGPSM2024-08-02

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