CALAJECT

GUDID 05713513000942

Computer-assisted dental injection syringe

Rønvig Dental Manufacturing A/S

Dental computer assisted anaesthesia injection unit
Primary Device ID05713513000942
NIH Device Record Keyd81d557f-0a97-4102-b52a-72ab69e3781e
Commercial Distribution StatusIn Commercial Distribution
Brand NameCALAJECT
Version Model Number2118
Company DUNS307549241
Company NameRønvig Dental Manufacturing A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8662442954
Emailorders@aseptico.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105713513000942 [Primary]

FDA Product Code

EJISyringe, Cartridge

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05713513000942]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-09-28

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 PREP2022-10-05 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

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