FDA.reportPublic FDA data

CTT CERAMIC TISSUE TRIMMER

Primary DI
05713513000157
Brand
CTT CERAMIC TISSUE TRIMMER
Company
Rønvig Dental Manufacturing A/S
Model
24017
Device description
A rotating instrument used for minor surgical procedures in dentistry.
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
DZADrill, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713513000157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713513000157057135130001575713513000157

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic dental burA rotary cutting device, the working end of which is made from ceramic, designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth and bone. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
307549241
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05713513000942CALAJECT21182017-09-28
05713513000164DENTO PREP19002022-09-27
05713513001307COMPO-JECT 2.0 black handle200062026-04-14
05713513001185ASPIJECT Active Compact20412025-02-27
05713513000089CONTA-GUARD22002022-09-28
05713513000119COMPO-JECT 200032022-09-28
05713513000362CONTA-GUARD 22222022-09-28
05713513001000EASE-IT200202022-09-28
05713513000010ASPIJECT20552017-08-25
05713513000058PAROJECT20182017-08-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08059224218038INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
08059224218250INVASIVE ACCESSORIES AND INSTRUMENTSRHEIN 83 SRLDZA2026-08-27
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