DEVICE: ULTRAFLEX (D810PUFDFPFEK11)

Device Identifier (DI) Information

ULTRAFLEX
PUFDFPFEK1
In Commercial Distribution
PUFDFPFEK1
ASTRON DENTAL CORPORATION
D810PUFDFPFEK11
HIBCC

1
056624901 *Terms of Use
DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID
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Device Characteristics

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

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Mouthguard, custom-made A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made from impressions of the dental arch, and some types are referred to as nightguards or bite raising appliances. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K874025 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5ac11598-bcf6-4177-8667-75718a1edc3a
July 06, 2018
4
September 07, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
847-726-8787
ASTRONCORP@AOL.COM
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