FDA.report

Premium Plus

Primary DI
D8387502T8
Brand
Premium Plus
Company
Premium Plus International Limited
Model
7502T
Device description
Brush Handle
Published
2020-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NRDUnit, Operative Dental, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
NRDUnit, Operative Dental, AccessoriesDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8387502T8PackageHIBCC100In Commercial Distribution
D8387502T4PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental material application tool, reusableA hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
668367758
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D83822098Premium Plus22092022-02-28
D838300ASS2Premium Plus300-ASS2019-05-19
D8382288TB8Premium Plus2288TB2020-10-10
D8382288TG8Premium Plus2288TG2020-10-10
D8382288TL8Premium Plus2288TL2020-10-10
D8382288TP8Premium Plus2288TP2020-10-10
D8382288TW8Premium Plus2288TW2020-10-10
D838FS2288B8Premium PlusFS2288B2020-10-10
D838FS2288G8Premium PlusFS2288G2020-10-10
D838FS2288L8Premium PlusFS2288L2020-10-10
D838FS2288P8Premium PlusFS2288P2020-10-10
D838FS2288W8Premium PlusFS2288W2020-10-10
D8382288F18Premium Plus2288F12019-12-27
D8382288F28Premium Plus2288F22019-12-27
D8382288F38Premium Plus2288F32019-12-27
D8382288F48Premium Plus2288F42019-12-27
D8382288KID8Premium Plus2288KID2019-12-27
D8382288L18Premium Plus2288L12019-12-27
D8382288L28Premium Plus2288L22019-12-27
D8382288L38Premium Plus2288L32019-12-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
D12517802Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517812Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
D12517822Premium PlusPremium Plus (Dongguan) LimitedNRD2026-05-22
00810126506511Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506528Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
00810126506535Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCNRD2025-12-16
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
00371347017878Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
00371347017885Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-24
00371347017830Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017847Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017854Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
00371347017861Advance Dental ProductsThe Atlanta Dental Supply CompanyNRD2025-11-18
06971119541897Air compressor Guangdong JINME Medical Technology Co., Ltd.NRD2025-07-23
06971119541903Testing machineGuangdong JINME Medical Technology Co., Ltd.NRD2025-07-23
10194665007935ActeonA-DEC, INC.NRD2025-05-15
D1302HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D1303HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D1304HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130BVM10BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130BVM20BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D130HD40BaseVacR. E. Morrison Equipment IncNRD2025-05-14
D678AS50X1AirStarAIR TECHNIQUES, INC.NRD2025-04-25
D678AS70X0AirStarAIR TECHNIQUES, INC.NRD2025-04-25
00304040190371Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190388Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190395Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21
00304040190401Henry ScheinHENRY SCHEIN, INC.NRD2025-03-21