Cerinate Prime® 1397

GUDID D81313970

Dentine bonding agent/set

Primary Device ID	D81313970
NIH Device Record Key	7729e076-7356-4641-b8dd-e9d2139bf5c0
Commercial Distribution Status	In Commercial Distribution
Brand Name	Cerinate Prime®
Version Model Number	1397
Catalog Number	1397
Company DUNS	809857704
Company Name	DEN-MAT HOLDINGS, 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	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

Device Issuing Agency	Device ID
HIBCC	D81313970 [Primary]

DYH	Adhesive, Bracket And Tooth Conditioner, Resin

Steralize Prior To Use	false
Device Is Sterile	false

03598833235166 - EVANESCE	2025-01-07 EVANESCE INJECTABLE ENW SYR
03598833235265 - EVANESCE	2025-01-07 EVANESCE EVANESCE INJECTABLE
03598833235272 - EVANESCE	2025-01-07 EVANESCE INJECTABLE A2U SYR
03598833235289 - EVANESCE	2025-01-07 EVANESCE INJECTABLE B1U SYR
03598833235296 - EVANESCE	2025-01-07 EVANESCE INJECTABLE BL1U SYR
03598833235302 - EVANESCE	2025-01-07 EVANESCE INJECTABLE A3U SYR
00359883973216 - EVANESCE	2024-12-23 EVANESCE BULK CURE A2 SY 1x3g
03598833215236 - EVANESCE	2024-12-23 EVANESCE BULK FILL A2 SY 1X6G

Mark Image Registration \| Serial	Company Trademark Application Date
CERINATE PRIME 87296910 5368120 Live/Registered	Den-Mat Holdings, LLC 2017-01-11
CERINATE PRIME 73627423 1471916 Live/Registered	DEN-MAT, INC. 1986-10-28