Thermique™ D533

GUDID M595D5330

Large Thermique™ Condenser Tip

PARKELL, INC.

Endodontic obturation system

• Primary Device ID: M595D5330
• NIH Device Record Key: 9016c09e-b8c9-44fa-a386-a1c928e7b5d9
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Thermique™
• Version Model Number: D533
• Catalog Number: D533
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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: false
• 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

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595D5330 [Primary]

FDA Product Code

• EAT: Tester, Pulp

Sterilization

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

[M595D5330]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-01
• Device Publish Date: 2016-09-23

On-Brand Devices [Thermique™]

• 00810000520800: Large Thermique™ Condenser Tip
• 00810000520794: Medium Thermique™ Condenser Tip
• 00810000520787: Fine Thermique™ Condenser Tip
• M595D5330: Large Thermique™ Condenser Tip
• M595D5320: Medium Thermique™ Condenser Tip
• M595D5310: Fine Thermique™ Condenser Tip