FDA.report

Premium Plus

Primary DI
D8384608
Brand
Premium Plus
Company
Premium Plus International Limited
Model
460
Device description
MIXING BOWLS
Published
2019-12-27
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
JDZMixer, Cement, For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8384606PackageHIBCC10In Commercial Distribution
D8384608PackageHIBCC4In Commercial Distribution
D8384604PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental material mixing surface, reusableA slab, tray, or well intended to be used as a surface for mixing inactive dental component materials chairside to produce a functional dental restorative/impression material that is immediately applied to the oral cavity/teeth of the patient, or extraorally to a dental restoration, during a dental procedure. It is typically made of plastic or glass and the user will ordinarily mix the component materials on or in the device by hand (e.g., with a spatula or brush). This is a reusable device.

Sterilization Methods

Method

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
false

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
04250203943482QuattroMixJoline GmbH & Co. KGJDZ2026-03-03
25060238201920Vacuum Cement Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-11-18
25060238201722Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201739Quick-Vac® Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201746HiVac BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201753Rally™ Vacuum Mixing BowlSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201784 MiniMix™SUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201791MiniMix™ LVSUMMIT MEDICAL LIMITEDJDZ2025-01-10
25060238201883Mixing bowl, SpatulaSUMMIT MEDICAL LIMITEDJDZ2025-01-10
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONJDZ2024-11-21
07613327547535AutoPlex M4STRYKER CORPORATIONJDZ2024-11-21
08058964723758Disp. Mixing Bowl-OG21 SRLJDZ2024-10-14
08058964728654Arthrex Bone Cement Mixing Syringe G21 SRLJDZ2024-10-14
08058964728715Arthrex Bone Cement Open Mixing BowlG21 SRLJDZ2024-10-14
08058964728753Arthrex Bone Cement Closed Mixing Bowl G21 SRLJDZ2024-10-14
08058964729057Arthrex Bone Cement Closed Mixing Bowl G21 SRLJDZ2024-10-14
08058964729064Arthrex Bone Cement Mixing Syringe G21 SRLJDZ2024-10-14
08058964724564PicoMix VG21 SRLJDZ2024-10-10
08058964724670PicoMix BowlG21 SRLJDZ2024-10-10
08058964725042PicoMix SyringeG21 SRLJDZ2024-10-10
08058964726261PicoMix SyringeG21 SRLJDZ2024-10-10
08058964727831PicoMix BowlG21 SRLJDZ2024-10-10
08058964727848PicoMix SyringeG21 SRLJDZ2024-10-10
06951233721610CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721634CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721658CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721665CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721672CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721696CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15
06951233721719CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.JDZ2024-05-15