FDA.reportPublic FDA data

EASE-IT

Primary DI
05713513001000
Brand
EASE-IT
Company
Rønvig Dental Manufacturing A/S
Model
20020
Device description
Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materials.
Published
2022-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EEGHeat Source For Bleaching Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEGHeat Source For Bleaching TeethDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713513001000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713513001000057135130010005713513001000

GMDN Terms#

Term, Definition table
TermDefinition
Dental material heaterAn electrically-powered device designed to be used to heat, through conduction, a variety of materials/substances (e.g., composite resin, root canal cleaning solution, local anaesthetic agent) to facilitate application of the material (e.g., optimum performance, patient comfort) during a dental procedure. It consists of a heating element with a temperature controller and a heater plate.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
307549241
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713513001307COMPO-JECT 2.0 black handle200062026-04-14
05713513000942CALAJECT21182017-09-28
05713513001185ASPIJECT Active Compact20412025-02-27
05713513000089CONTA-GUARD22002022-09-28
05713513000119COMPO-JECT 200032022-09-28
05713513000157CTT CERAMIC TISSUE TRIMMER240172022-09-28
05713513000362CONTA-GUARD 22222022-09-28
05713513000164DENTO PREP19002022-09-27
05713513000010ASPIJECT20552017-08-25
05713513000058PAROJECT20182017-08-25

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Primary DI, Brand, Company table
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E241BW0080Cavex Bite&White 3 syringes CP22Cavex Holland B.V.EEG2026-03-05
E241BW0310Cavex Bite&White Ready 2 UseCavex Holland B.V.EEG2026-03-05
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E241BW0510Cavex Bite&White In-Office 25% Pen bulkCavex Holland B.V.EEG2026-03-05
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