Acero Crowns ES

GUDID 00810120870540

Preformed dental crown, temporary

Primary Device ID	00810120870540
NIH Device Record Key	16da9561-1083-4b26-87e8-88530078b06c
Commercial Distribution Status	In Commercial Distribution
Brand Name	Acero Crowns ES
Version Model Number	ES E1
Company DUNS	006672536
Company Name	Park - Istre, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00810120870540 [Primary]

ELZ	Crown, Preformed

Steralize Prior To Use	false
Device Is Sterile	false