ProRoot MTA PRCEM

GUDID D716PRCEM1

ProRoot: Gray MTA

TULSA DENTAL PRODUCTS LLC

Dental unfilled resin sealant/coating

• Primary Device ID: D716PRCEM1
• NIH Device Record Key: ba54f0b5-e46e-4f15-8044-65174fa6c5f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProRoot MTA
• Version Model Number: PRCEM
• Catalog Number: PRCEM
• Company DUNS: 942778564
• Company Name: TULSA DENTAL PRODUCTS LLC
• Device Count: 5
• 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

Customer Support Contacts

• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com
• Phone: +1(800)662-1202
• Email: tulsa.orders@dentsply.com

Device Dimensions

• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram
• Weight: 1 Gram

Operating and Storage Conditions

• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	D716PRCEM0 [Unit of Use]
HIBCC	D716PRCEM1 [Primary]

FDA Product Code

• KIF: RESIN, ROOT CANAL FILLING

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-11-04
• Device Publish Date: 2016-10-07

On-Brand Devices [ProRoot MTA]

• 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