DEVICE: DAPDISH (D832901DD11)

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Device Record History
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Device Identifier (DI) Information
DAPDISH
901DD-1
In Commercial Distribution
901DD-1
PLASDENT CORPORATION
D832901DD11
HIBCC

200
190377184 *Terms of Use
Dappen Dishes, White
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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
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FDA Product Code

[?]
Product Code Product Code Name
NRD Unit, Operative Dental, Accessories
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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
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
f5019184-4edd-45dc-b644-74c3aa013f2a
January 24, 2022
1
January 14, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
D832901DDB11 1000 D832901DD11 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: D832901DD10 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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