ProRoot MTA PRSLENS8

GUDID D716PRSLENS8

MTA ProRoot Carrier Sleeves NS8mm

TULSA DENTAL PRODUCTS LLC

Dental amalgam carrier

• Primary Device ID: D716PRSLENS8
• NIH Device Record Key: 295a5f59-d69e-4d99-b7af-13d5ecfc4f03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProRoot MTA
• Version Model Number: PRSLENS8
• Catalog Number: PRSLENS8
• Company DUNS: 942778564
• Company Name: TULSA DENTAL PRODUCTS 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D716PRSLENS8 [Primary]

FDA Product Code

• EKK: SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

Sterilization

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

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

[D716PRSLENS8]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-08
• Device Publish Date: 2022-08-31

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