FDA.report

Premier X5 Sectional Matrix System

Primary DI
00348783004656
Brand
Premier X5 Sectional Matrix System
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9061172
Device description
Premier X5 Wedge Large Blue-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

Related Records

Product Codes

CodeName
JEPRetainer, Matrix

Product Code Classifications

CodeDeviceSpecialtyClass
JEPRetainer, MatrixDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00348783004656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783004656003487830046563487830046560348783004656

GMDN Terms

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

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

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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
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