PAROJECT

GUDID 05713513000058

Intraligamental injection syringe

Rønvig Dental Manufacturing A/S

Dental anaesthesia syringe, intraligamentary
Primary Device ID05713513000058
NIH Device Record Key367aacb5-e182-487e-b0b9-43b8fc677425
Commercial Distribution StatusIn Commercial Distribution
Brand NamePAROJECT
Version Model Number2018
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 Dimensions

Total Volume1.8 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS105713513000058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EGMInjector, Jet, Mechanical-Powered

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05713513000058]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-08-25

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 - PAROJECT2018-07-06Intraligamental injection syringe
05713513000058 - PAROJECT2018-07-06 Intraligamental injection syringe

Trademark Results [PAROJECT]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PAROJECT
PAROJECT
74561977 1914746 Live/Registered
Ronvig, Jorn
1994-08-17

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