AccessGUDID - DEVICE: Prodent (06970553800178)

GUDID

Device Identifier (DI) Information

Brand Name: Prodent
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Prodent Dental Technology (Shenzhen) Co., Ltd.

Primary DI Number: 06970553800178
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 421194088 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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

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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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ae9bb7f2-6765-455c-aa46-baa5722ad26e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 06, 2016