FDA.report

Premier X5 Sectional Matrix System

Primary DI
00348783004571
Brand
Premier X5 Sectional Matrix System
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9061150
Device description
Premier X5 Intro Kit
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
00348783004571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783004571003487830045713487830045710348783004571

GMDN Terms

TermDefinition
Dental matrix band kitA collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
014789663
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
true

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008101265081953D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCJEP2026-03-16
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