Royal Coral Red Polymer 16

GUDID D85116

Dental appliance fabrication material, cured

Primary Device ID	D85116
NIH Device Record Key	44a2f112-3d8b-4a92-b8e6-28e85ebe3ca2
Commercial Distribution Status	In Commercial Distribution
Brand Name	Royal Coral Red Polymer
Version Model Number	16
Catalog Number	16
Company DUNS	080390783
Company Name	JBC and Company
Device Count	1
DM Exempt	false
Pre-market Exempt	false
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	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D85116 [Primary]

EBI	Resin, Denture, Relining, Repairing, Rebasing

Steralize Prior To Use	false
Device Is Sterile	false

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D85102 - Luminary Pink Polymer	2018-10-16 Tinted Glow Powder
D85103 - Luminary Coral Red Polymer	2018-10-16 Tinted Glow Powder
D85104 - Luminary Orange Polymer	2018-10-16 Tinted Glow Powder
D85105 - Luminary Blaze Yellow Polymer	2018-10-16 Tinted Glow Powder
D85106 - Luminary Yellow Polymer	2018-10-16 Tinted Glow Powder
D85107 - Luminary Green Polymer	2018-10-16 Tinted Glow Powder
D85108 - Luminary Teal Polymer	2018-10-16 Tinted Glow Powder