FDA.reportPublic FDA data

Premier X5 Sectional Matrix System

Primary DI
00348783004649
Brand
Premier X5 Sectional Matrix System
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9061171
Device description
Premier X5 Wedge Medium Green-Qty 100
Published
2024-07-12
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
JEPRetainer, Matrix

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00348783004649PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783004649003487830046493487830046490348783004649

GMDN Terms#

Term, Definition table
TermDefinition
Dental wedge, single-useA small, dental device intended to be introduced between two adjacent teeth for slight separation during a dental procedure. It is typically used during the placement of a filling material, or to stabilize and support other devices (e.g., a matrix band and/or rubber dam). It may include a removable shield intended to protect the healthy tooth/teeth from damage by the instruments. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783011913Poli-Pro Disks20190702026-05-26
00348783011937Poli-Pro Disks20190712026-05-26
00348783011951Poli-Pro Disks20190732026-05-26
00348783004069Premier Elevator100336010033622026-03-17
00348783004076Premier Elevator100336110033632026-03-17
00348783004182Premier Elevator100338410033862026-03-17
00348783004229Premier Elevator100339410033962026-03-17
00348783005929Premier Explorers10035092026-03-17
00348783005974Premier Explorers10035152026-03-17
00348783005998Premier Explorers10035232026-03-17
00348783006018Premier Explorers10035262026-03-17
00348783006056Premier Explorers10035392026-03-17
00348783006063Premier Explorers10035492026-03-17
00348783006186Premier Explorers10035602026-03-17
00348783006223Premier Explorers10035652026-03-17
00348783006438Premier Probes10036702026-03-17
00348783006629Premier Probes10036902026-03-17
00348783006766Premier Probes90061022026-03-17
00348783006780Premier Probes90061052026-03-17
00348783006803Premier Probes90061072026-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008101265081643D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081713D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081883D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
008101265081953D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
00840456215227Generic Packing (No Brand)JMU DENTAL, INCJEP2025-08-18
00840456215234Generic Packing (No Brand)JMU DENTAL, INCJEP2025-08-18
00840456213537JMUJMU DENTAL, INCJEP2025-06-25
00840456213544JMUJMU DENTAL, INCJEP2025-06-25
00840456213551JMUJMU DENTAL, INCJEP2025-06-25
00840456213568JMUJMU DENTAL, INCJEP2025-06-25
00850056330718White BiteWhite Bite, Inc.JEP2025-06-10
00850056330701White BiteWhite Bite, Inc.JEP2025-05-16
00686864061151MEDICOM SAFEMATRIXAMD Medicom IncJEP2025-03-18
10840326423858AstekYoung Innovations, Inc.JEP2025-03-17
10840326423865AstekYoung Innovations, Inc.JEP2025-03-17
10840326423872AstekYoung Innovations, Inc.JEP2025-03-17
10840326423889AstekYoung Innovations, Inc.JEP2025-03-17
00810038091129Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091136Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091143Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091150Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091167Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091174Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091181Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091198Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091204Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091211Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091228Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091235Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16
00810038091242Quad Matrix System™GARRISON DENTAL SOLUTIONS, L.L.C.JEP2025-02-16