ACRY SMART 1 ST 0120103

GUDID 18056865121038

DENTAL MANUFACTURING SPA

Resin artificial teeth
Primary Device ID18056865121038
NIH Device Record Key5f66aa72-c9f5-46d6-97f3-9ea7b790bfc3
Commercial Distribution StatusIn Commercial Distribution
Brand NameACRY SMART 1 ST
Version Model NumberACRY SMART 1 ST 8 LOWER
Catalog Number0120103
Company DUNS435782248
Company NameDENTAL MANUFACTURING SPA
Device Count8
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS108056865121031 [Primary]
GS118056865121038 [Unit of Use]

FDA Product Code

PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-06
Device Publish Date2020-02-27

On-Brand Devices [ACRY SMART 1 ST ]

18056865121038ACRY SMART 1 ST 8 LOWER
18056865121021ACRY SMART 1 ST 8 UPPER
28056865012906ACRY SMART 1 ST 8 LOWER

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