ProRoot MTA PROROOT2W

GUDID D716PROROOT2W1

Dental unfilled resin sealant/coating

Primary Device ID	D716PROROOT2W1
NIH Device Record Key	af86a9aa-6453-4a1b-86bc-3b7936856de1
Commercial Distribution Status	In Commercial Distribution
Brand Name	ProRoot MTA
Version Model Number	PROROOT2W
Catalog Number	PROROOT2W
Company DUNS	942778564
Company Name	TULSA DENTAL PRODUCTS LLC
Device Count	4
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
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

Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place
Special Storage Condition, Specify	Between 0 and 0 *Store in a Cool Dry Place

Device Issuing Agency	Device ID
HIBCC	D716PROROOT2W0 [Unit of Use]
HIBCC	D716PROROOT2W1 [Primary]

KIF	RESIN, ROOT CANAL FILLING

Steralize Prior To Use	false
Device Is Sterile	false

D716PRSLENS8	MTA ProRoot Carrier Sleeves NS8mm
D716PRMSURR1	PROROOT:MTA MANUAL CARRIERS SR
D716PRMSURL1	PROROOT:MTA MANUAL CARRIERS SL
D716PRMSURC1	PROROOT:MTA MANUAL CARRIERS SC
D716PRMNS1	ProRoot: MTA MANUAL CARRIERS NS
D716PROROOT5W1	ProRoot MTA White - 0.5g pack (5g/box)
D716PROROOT2W1	ProRoot MTA White - 0.5g pack (2g/box)
D716PRCEMW1	Proroot CEM: White MTA 5 ct Package
D716PRCEM1	ProRoot: Gray MTA