Lamina Porcelain 6952

GUDID E23569520

Lamina Porcelain 15g LM A

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic
Primary Device IDE23569520
NIH Device Record Key9cea1503-7693-4780-ba5f-02954e494b67
Commercial Distribution StatusIn Commercial Distribution
Brand NameLamina Porcelain
Version Model Number6952
Catalog Number6952
Company DUNS054618202
Company NameSHOFU DENTAL CORPORATION
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone760-566-3528
Emailckaemmerlen@shofu.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23569520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-24
Device Publish Date2016-09-26

On-Brand Devices [Lamina Porcelain]

E23569560Lamina Porcelain 15g LM D
E23569550Lamina Porcelain 15g LM B
E23569540Lamina Porcelain 15g LM A
E23569530Lamina Porcelain 15g LM A
E23569520Lamina Porcelain 15g LM A
E23569510Lamina Porcelain 15g LM A

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