FDA.report

Premium Plus

Primary DI
D12517802
Brand
Premium Plus
Company
Premium Plus (Dongguan) Limited
Model
178-0
Device description
PSP Protective Paper Covers
Published
2026-05-22
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
NRDUnit, Operative Dental, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D12517808PackageHIBCC100In Commercial Distribution
D12517802PrimaryHIBCC0
D12517800Unit of UseHIBCC0

GMDN Terms

TermDefinition
Digital imaging cassetteA device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device.

Regulatory Flags

DUNS number
541637603
Device count
100
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 DIBrandModelCatalogPublished
D125100B2Premium Plus100B2026-05-22
D125100C2Premium Plus100C2026-05-22
D1251012Premium Plus1012026-05-22
D1251022Premium Plus1022026-05-22
D1251032Premium Plus1032026-05-22
D125104L2Premium Plus104L2026-05-22
D125104S2Premium Plus104S2026-05-22
D1251062Premium Plus1062026-05-22
D1251072Premium Plus1072026-05-22
D1251082Premium Plus1082026-05-22
D1251092Premium Plus1092026-05-22
D1251112Premium Plus1112026-05-22
D1251122Premium Plus1122026-05-22
D1251132Premium Plus1132026-05-22
D1251142Premium Plus1142026-05-22
D1251182Premium Plus1182026-05-22
D1251192Premium Plus1192026-05-22
D125123L2Premium Plus123L2026-05-22
D125123M2Premium Plus123M2026-05-22
D125123S2Premium Plus123S2026-05-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D12517812Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517822Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
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00810126506559Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506573Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00817169023708Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
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