P&R Repair Kit 1739

GUDID E23517390

Dental prosthesis restorative material, unfilled resin

Primary Device ID	E23517390
NIH Device Record Key	0ba30bb9-8d86-4a9a-afc4-a592cf4c9e54
Commercial Distribution Status	In Commercial Distribution
Brand Name	P&R Repair Kit
Version Model Number	1739
Catalog Number	1739
Company DUNS	054618202
Company Name	SHOFU DENTAL CORPORATION
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	false
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

Phone	760-566-3528
Email	ckaemmerlen@shofu.com

Handling Environment Temperature

Between 1 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	E23517390 [Primary]

KLE	Agent, Tooth Bonding, Resin

Steralize Prior To Use	false
Device Is Sterile	false