FDA.reportPublic FDA data

Premium Plus

Primary DI
D125921G2
Brand
Premium Plus
Company
Premium Plus (Dongguan) Limited
Model
921G
Device description
Micro Applicators
Published
2026-05-21
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
KXRApplicator, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXRApplicator, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D125921G6PackageHIBCC100In Commercial Distribution
D125921G8PackageHIBCC4In Commercial Distribution
D125921G2PrimaryHIBCC0
D125921G0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Regulatory Flags#

DUNS number
541637603
Device count
100
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D12518N4012Premium Plus18-N4012026-06-09
D12518N4022Premium Plus18-N4022026-06-09
D12518N4032Premium Plus18-N4032026-06-09
D12518N4042Premium Plus18-N4042026-06-09
D12518N4052Premium Plus18-N4052026-06-09
D12518S4012Premium Plus18-S4012026-06-09
D12518S4022Premium Plus18-S4022026-06-09
D12518S4032Premium Plus18-S4032026-06-09
D12518T4012Premium Plus18-T4012026-06-09
D12518T4022Premium Plus18-T4022026-06-09
D12518T4032Premium Plus18-T4032026-06-09
D1254334Premium Plus4332026-06-09
D1254344Premium Plus4342026-06-09
D1254354Premium Plus4352026-06-09
D1254364Premium Plus4362026-06-09
D1254374Premium Plus4372026-06-09
D1254384Premium Plus4382026-06-09
D1254394Premium Plus4392026-06-09
D1254404Premium Plus4402026-06-09
D1254514Premium Plus4512026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D1257500B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257500Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257501Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502T4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257502W4Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257510Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511G2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D1257511Y2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125902D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125902TLG1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903T2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125903TLL1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904D2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904T2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125904TWT1002Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125921B2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21
D125921L2Premium PlusPremium Plus (Dongguan) LimitedKXR2026-05-21