Prosthesis, Hawley Retainer, Palatal Expander, Spa

GUDID 06970617030100

SHENZHEN MINGHAO DENTURES CO., LTD.

Orthodontic retainer
Primary Device ID06970617030100
NIH Device Record Key116a7fdd-f13b-42be-8604-f4d93126a520
Commercial Distribution StatusIn Commercial Distribution
Brand NameProsthesis, Hawley Retainer, Palatal Expander, Spa
Version Model NumberNot Applicable
Company DUNS526027843
Company NameSHENZHEN MINGHAO DENTURES CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106970617030100 [Primary]

FDA Product Code

NSRProsthesis, Orthodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[06970617030100]

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[06970617030100]

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[06970617030100]

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[06970617030100]

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[06970617030100]

Ultraviolet Light


[06970617030100]

Ultraviolet Light


[06970617030100]

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[06970617030100]

Ultraviolet Light


[06970617030100]

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[06970617030100]

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Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-14

Devices Manufactured by SHENZHEN MINGHAO DENTURES CO., LTD.

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06970617030070 - System, Optical Impression, CAD/CAM: Crown, Bridge2018-07-24
06970617030018 - Restoration, Noble Metal--Noble Alloy: Crown, Brid2018-03-29
06970617030025 - Restoration, Resin: Nightguard, Splint2018-03-29
06970617030032 - Restoration, Resin: Crown, Bridge, Temporary Inlay2018-03-29
06970617030049 - Restoration, Porcelain Fused to Metal-PFM, Crown,B2018-03-29
06970617030063 - Restoration, Base Metal-BaseAlloy: Crown,Bridge, I2018-03-29
06970617030087 - Dentures, Partial-Partial Denture, RPD 2018-03-29

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