EASE-IT

GUDID 05713513001000

Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materials.

Rønvig Dental Manufacturing A/S

Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater Dental material heater

• Primary Device ID: 05713513001000
• NIH Device Record Key: 5a9e8d81-f70d-45c8-8361-d040db3c3ed0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EASE-IT
• Version Model Number: 20020
• Company DUNS: 307549241
• Company Name: Rønvig Dental Manufacturing A/S
• 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: false
• Serial Number: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713513001000 [Primary]

FDA Product Code

• EEG: Heat Source For Bleaching Teeth

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-06
• Device Publish Date: 2022-09-28

Devices Manufactured by Rønvig Dental Manufacturing A/S

• 05713513000089 - CONTA-GUARD: 2022-10-06 200 pcs. of laminated disposable foil for protection against needle stick.
• 05713513000119 - COMPO-JECT: 2022-10-06 Composite Applicator for delivery of dental materials in pre-filled unit-dose tips for direct oral application.
• 05713513000157 - CTT CERAMIC TISSUE TRIMMER: 2022-10-06 A rotating instrument used for minor surgical procedures in dentistry.
• 05713513000362 - CONTA-GUARD: 2022-10-06 A autoclavable Recapping Stand for one-handed handling of injection needles to avoid needle stick injuries.
• 05713513001000 - EASE-IT: 2022-10-06Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materials.
• 05713513001000 - EASE-IT: 2022-10-06 Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materia
• 05713513000164 - DENTO PREP: 2022-10-05 Dental Micro-blaster for use with aluminium oxide powder.
• 05713513000010 - ASPIJECT: 2018-11-22 Self-aspirating dental injection syringe for 1.8 ml standard dental cartridges
• 05713513000058 - PAROJECT: 2018-07-06 Intraligamental injection syringe