DEVICE: Prodent (06970553800041)

Device Identifier (DI) Information

Prodent
1602203B
In Commercial Distribution

Prodent Dental Technology (Shenzhen) Co., Ltd.
06970553800041
GS1

1
421194088 *Terms of Use
No description.
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Device Characteristics

MR Unsafe
No
No
No
No
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Dental bridge, ceramic A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.
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FDA Product Code

[?]
Product Code Product Code Name
ELL Teeth, Porcelain
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K781935 000
No 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

4bf8b5e4-005c-4c4c-910d-80273e9eac14
July 06, 2018
3
August 26, 2016
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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
No Package DIs found
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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