FDA.reportPublic FDA data

Premium Plus

Primary DI
D1254124
Brand
Premium Plus
Company
Premium Plus (Dongguan) Limited
Model
412
Device description
Dental Impression Trays
Published
2026-05-27
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
EHYTray, Impression, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D1254126PackageHIBCC10In Commercial Distribution
D1254128PackageHIBCC4In Commercial Distribution
D1254124PrimaryHIBCC0
D1254120Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray, single-useA horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.

Regulatory Flags#

DUNS number
541637603
Device count
10
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D1250802Premium Plus0802026-05-27
D1250812Premium Plus0812026-05-27
D1250822Premium Plus0822026-05-27
D1254104Premium Plus4102026-05-27
D1254114Premium Plus4112026-05-27
D1254134Premium Plus4132026-05-27
D1254144Premium Plus4142026-05-27
D1254154Premium Plus4152026-05-27
D1254164Premium Plus4162026-05-27
D1254174Premium Plus4172026-05-27
D1254184Premium Plus4182026-05-27
D1254194Premium Plus4192026-05-27
D1254204Premium Plus4202026-05-27
D1254304Premium Plus4302026-05-27
D125780MLB2Premium Plus780MLB2026-05-27
D125780MW2Premium Plus780MW2026-05-27
D125780SLB2Premium Plus780SLB2026-05-27
D125780SW2Premium Plus780SW2026-05-27
D125YS10012Premium PlusYS10012026-05-27
D125YS10022Premium PlusYS10022026-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D1254104Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254114Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254134Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254144Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254154Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254164Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254174Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254184Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254194Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254204Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
D1254304Premium PlusPremium Plus (Dongguan) LimitedEHY2026-05-27
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