DENTO PREP

GUDID 05713513000164

Dental Micro-blaster for use with aluminium oxide powder.

Rønvig Dental Manufacturing A/S

Dental abrasive air jet system
Primary Device ID05713513000164
NIH Device Record Key6ab89c06-e762-49c1-b6cf-2db6efdf643c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDENTO PREP
Version Model Number1900
Company DUNS307549241
Company NameRønvig Dental Manufacturing A/S
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS105713513000164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KOJAirbrush

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


[05713513000164]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-05
Device Publish Date2022-09-27

Devices Manufactured by Rønvig Dental Manufacturing A/S

05713513000089 - CONTA-GUARD2022-10-06 200 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 TRIMMER2022-10-06 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-IT2022-10-06 Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materia
05713513000164 - DENTO PREP2022-10-05Dental Micro-blaster for use with aluminium oxide powder.
05713513000164 - DENTO PREP2022-10-05 Dental Micro-blaster for use with aluminium oxide powder.
05713513000010 - ASPIJECT2018-11-22 Self-aspirating dental injection syringe for 1.8 ml standard dental cartridges
05713513000058 - PAROJECT2018-07-06 Intraligamental injection syringe

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.