ACRY CETTE 0130002

GUDID 18056865013029

DENTAL MANUFACTURING SPA

Resin artificial teeth
Primary Device ID18056865013029
NIH Device Record Key4665bde7-3b32-4a0c-8ff7-2454d73d2d85
Commercial Distribution StatusIn Commercial Distribution
Brand NameACRY CETTE
Version Model NumberACRY CETTE 6 LOWER
Catalog Number0130002
Company DUNS435782248
Company NameDENTAL MANUFACTURING SPA
Device Count6
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
GS108056865013022 [Primary]
GS118056865013029 [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 Date2020-02-19
Device Publish Date2020-02-11

On-Brand Devices [ACRY CETTE ]

18056865013043ACRY CETTE 8 LOWER
18056865013036ACRY CETTE 8 UPPER
18056865013029ACRY CETTE 6 LOWER
18056865013012ACRY CETTE 6 UPPER

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