FDA.reportPublic FDA data

Paradigm BX

Primary DI
D948PBXM3N250
Brand
Paradigm BX
Company
Smarter Alloys Inc
Model
M3
Catalog number
PBX-M3-N25
Device description
Multi-taper NiTi rotary endodontic file, size M3, 25mm length
Published
2020-05-21
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

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
D948PBXM3N251PrimaryHIBCC0
D948PBXM3N250Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Rotary/reciprocating endodontic file/rasp, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
200106716
Device count
6
DM exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D948PBXLGH251Paradigm QuantumLGHTPBX-LG-H252021-08-25
D948PBXMDH251Paradigm QuantumMDHTPBX-MD-H252021-08-25
D948PBXPRH251Paradigm QuantumPRHTPBX-PR-H252021-08-25
D948PBXSMH251Paradigm QuantumSMHTPBX-SM-H252021-08-25
D948PBXLGH250Paradigm QuantumLGHTPBX-LG-H252021-08-25
D948PBXMDH250Paradigm QuantumMDHTPBX-MD-H252021-08-25
D948PBXPRH250Paradigm QuantumPRHTPBX-PR-H252021-08-25
D948PBXSMH250Paradigm QuantumSMHTPBX-SM-H252021-08-25
D948SAODREL18250SmartArchSAO-DREL-18252021-04-05
D948SAODREU18250SmartArchSAO-DREU-18252021-04-05
D948SAODROL00160SmartArchSAO-DROL-00162021-04-05
D948SAODREL18251SmartArchSAO-DREL-18252021-04-05
D948SAODREU18251SmartArchSAO-DREU-18252021-04-05
D948SAODROL00161SmartArchSAO-DROL-00162021-04-05
D948SAODROU00160SmartArchSAO-DROU-00162021-04-05
D948PBXLGN251Paradigm QuantumLGPBX-LG-N252020-11-04
D948PBXMDN251Paradigm QuantumMDPBX-MD-N252020-11-04
D948PBXPRN251Paradigm QuantumPRPBX-PR-N252020-11-04
D948PBXSMN251Paradigm QuantumSMPBX-SM-N252020-11-04
D948PBXA1N251Paradigm BXA1PBX-A1-N252020-05-21

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