DEVICE: PMMA BLOCK (06970402677473)

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Device Identifier (DI) Information
PMMA BLOCK
Clear
In Commercial Distribution
11*1/BOX
SHANDONG HUGE DENTAL MATERIAL CORPORATION
06970402677473
GS1

1
528184691 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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?
31783 Temporary dental crown/bridge
A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].
Active false
38621 Mouthguard, reusable
A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device.
Active false
11172 Preformed complete denture
A prefabricated plastic plate designed to fit over an edentulous maxillary or mandibular alveolar ridge; an entire complement of artificial teeth from one arch is added to create a full denture. It is available in several standard sizes that can be contoured to custom fit the patient's ridge.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MQC Mouthguard, Prescription
EBI Resin, Denture, Relining, Repairing, Rebasing
EBG Crown And Bridge, Temporary, Resin
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K201683 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
6b8eb194-a173-43c6-ad8c-2bc34030e1a4
November 01, 2021
1
October 22, 2021
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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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