FDA.report

Premium Plus

Primary DI
D838004LAV8
Brand
Premium Plus
Company
Premium Plus International Limited
Model
004B-LAV
Device description
dappen dish
Published
2020-01-07
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
true

Related Records

Product Codes

CodeName
JDZMixer, Cement, For Clinical Use

Product Code Classifications

CodeDeviceSpecialtyClass
JDZMixer, Cement, For Clinical UseOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D838004LAV6PackageHIBCC5In Commercial Distribution
D838004LAV8PackageHIBCC4In Commercial Distribution
D838004LAV2PrimaryHIBCC0
D838004LAV0Unit of UseHIBCC0

GMDN Terms

TermDefinition
Dappen dish, single-useA small, shallow concave vessel made of a thermoplastic material used to mix dental materials chairside prior to application to the patient during dental procedures. The device is typically placed in a holder while the user dispenses the required amount of component materials into it and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. The device will then be placed in a hand-held holder for patient application. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
668367758
Device count
200
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

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D838FS2288P8Premium PlusFS2288P2020-10-10
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D8382288F28Premium Plus2288F22019-12-27
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D8382288F48Premium Plus2288F42019-12-27
D8382288KID8Premium Plus2288KID2019-12-27
D8382288L18Premium Plus2288L12019-12-27
D8382288L28Premium Plus2288L22019-12-27
D8382288L38Premium Plus2288L32019-12-27

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