DEVICE: Premium Plus (D838010ASS4)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Premium Plus
010-ASS
In Commercial Distribution

Premium Plus International Limited
D838010ASS4
HIBCC

200
668367758 *Terms of Use
Disposable prophy rings
CLOSE

Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45120 Dappen dish, single-use
A 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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JDZ Mixer, Cement, For Clinical Use
CLOSE

FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
7365b475-7aa6-45dc-8501-fb3cf61cadcb
January 15, 2020
1
January 07, 2020
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D838010ASS8 4 D838010ASS6 In Commercial Distribution CASE
D838010ASS6 10 D838010ASS4 In Commercial Distribution BOX
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: D838010ASS0 CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE