FDA.reportPublic FDA data

Paradigm Quantum

Primary DI
D948PBXPRH251
Brand
Paradigm Quantum
Company
Smarter Alloys Inc
Model
PRHT
Catalog number
PBX-PR-H25
Device description
.07v taper NiTi reciprocating endodontic file, size primary, 25mm length, heat treated
Published
2021-08-25
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
D948PBXPRH251PrimaryHIBCC0
D948PBXPRH250Unit 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
Premarket exempt
true
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
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
D948PBXA2N251Paradigm BXA2PBX-A2-N252020-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877830090EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830106EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
06941877830113EighteethChangzhou Sifary Medical Technology Co., Ltd.EKS2026-06-09
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