ZIRCONIA PRIME 049019200

GUDID D8130490192000

Diamond dental bur, reusable

Primary Device ID	D8130490192000
NIH Device Record Key	781eb53c-c088-4809-b2cd-7a26f2288e3d
Commercial Distribution Status	In Commercial Distribution
Brand Name	ZIRCONIA PRIME
Version Model Number	049019200
Catalog Number	049019200
Company DUNS	809857704
Company Name	DEN-MAT HOLDINGS, LLC
Device Count	5
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	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	D8130490192000 [Unit of Use]
HIBCC	D8130490192001 [Primary]

DZP	Instrument, Diamond, Dental

Steralize Prior To Use	false
Device Is Sterile	false

D8133900B0	ZIRCONIA PRIME
D8130490193000	ZR DIAMOND ROUND-END FLAME 5pc
D8130490192000	ZR DIAMOND FOOTBALL 5pc
D8130490191000	ZR DIAMOND PARALLEL CHAMFR 5pc

Mark Image Registration \| Serial	Company Trademark Application Date
ZIRCONIA PRIME 88525814 not registered Live/Pending	Den-Mat Holdings, LLC 2019-07-20