DEVICE: Prodent (06970553800178)
Device Identifier (DI) Information
Prodent
N/A
In Commercial Distribution
Prodent Dental Technology (Shenzhen) Co., Ltd.
N/A
In Commercial Distribution
Prodent Dental Technology (Shenzhen) Co., Ltd.
No description.
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 |
---|---|
Partial denture | A custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD). |
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. |
Dental bridge, metal-ceramic | A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELM | Denture, Plastic, Teeth |
ELL | Teeth, Porcelain |
EJH | Alloy, Metal, Base |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K020253 | 000 |
K781935 | 000 |
K792245 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ae9bb7f2-6765-455c-aa46-baa5722ad26e
July 06, 2018
3
September 06, 2016
July 06, 2018
3
September 06, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
10697055380017
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined