Hyramic CAD/CAM Restorative

GUDID 06941382251014

Liaoning Upcera Co.,Ltd.

Dental appliance fabrication material, ceramic
Primary Device ID06941382251014
NIH Device Record Key0755d620-540d-4801-8000-d82abc308201
Commercial Distribution StatusIn Commercial Distribution
Brand NameHyramic CAD/CAM Restorative
Version Model NumberLT-S-C4-R(18-14-12)
Company DUNS548214192
Company NameLiaoning Upcera Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106941382251014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin
EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-20
Device Publish Date2019-03-20

On-Brand Devices [Hyramic CAD/CAM Restorative]

06941382252486LT-M-D4-D(98-20)
06941382252479LT-M-D3-D(98-20)
06941382252462LT-M-D2-D(98-20)
06941382252455LT-M-C4-D(98-20)
06941382252448LT-M-C3-D(98-20)
06941382252431LT-M-C2-D(98-20)
06941382252424LT-M-C1-D(98-20)
06941382252417LT-M-B4-D(98-20)
06941382252400LT-M-B3-D(98-20)
06941382252394LT-M-B2-D(98-20)
06941382252387LT-M-B1-D(98-20)
06941382252370LT-M-A4-D(98-20)
06941382252363LT-M-A3.5-D(98-20)
06941382252356LT-M-A3-D(98-20)
06941382252349LT-M-A2-D(98-20)
06941382252332LT-M-A1-D(98-20)
06941382252325LT-S-D4-D(98-20)
06941382252318LT-S-D3-D(98-20)
06941382252301LT-S-D2-D(98-20)
06941382252295LT-S-C4-D(98-20)
06941382252288LT-S-C3-D(98-20)
06941382252271LT-S-C2-D(98-20)
06941382252264LT-S-C1-D(98-20)
06941382252257LT-S-B4-D(98-20)
06941382252240LT-S-B3-D(98-20)
06941382252233LT-S-B2-D(98-20)
06941382252226LT-S-B1-D(98-20)
06941382252219LT-S-A4-D(98-20)
06941382252202LT-S-A3.5-D(98-20)
06941382252196LT-S-A3-D(98-20)
06941382252189LT-S-A2-D(98-20)
06941382252172LT-S-A1-D(98-20)
06941382252165HT-M-D4-D(98-20)
06941382252158HT-M-D3-D(98-20)
06941382252141HT-M-D2-D(98-20)
06941382252134HT-M-C4-D(98-20)
06941382252127HT-M-C3-D(98-20)
06941382252110HT-M-C2-D(98-20)
06941382252103HT-M-C1-D(98-20)
06941382252097HT-M-B4-D(98-20)
06941382252080HT-M-B3-D(98-20)
06941382252073HT-M-B2-D(98-20)
06941382252066HT-M-B1-D(98-20)
06941382252059HT-M-A4-D(98-20)
06941382252042HT-M-A3.5-D(98-20)
06941382252035HT-M-A3-D(98-20)
06941382252028HT-M-A2-D(98-20)
06941382252011HT-M-A1-D(98-20)
06941382252004HT-S-D4-D(98-20)
06941382251991HT-S-D3-D(98-20)

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