FDA.reportPublic FDA data

PAROJECT

Primary DI
05713513000058
Brand
PAROJECT
Company
Rønvig Dental Manufacturing A/S
Model
2018
Device description
Intraligamental injection syringe
Published
2017-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EGMInjector, Jet, Mechanical-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGMInjector, Jet, Mechanical-PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K904279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K904279000PAROJECT ANESTHETIC SYRINGERonvig Instruments, Ltd.1990-12-07EGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05713513000058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05713513000058057135130000585713513000058

GMDN Terms#

Term, Definition table
TermDefinition
Dental anaesthesia syringe, intraligamentaryA hand-held manual dental device designed for injecting an anaesthetic agent under pressure via the periodontal ligament or into bone through an attached sterile needle. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.8Milliliter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
307549241
Device count
1
Lot or batch
true
Sterilization required before use
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
05713513001000EASE-IT200202022-09-28
05713513000164DENTO PREP19002022-09-27
05713513000010ASPIJECT20552017-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760349801054QUICKSLEEPER 5C_A2 US/CADENTALHITECEGM2025-12-22
00815160020580MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020610MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020627MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020634MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020641MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020658MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00303620000024PAROJECTSEPTODONT, INCEGM2016-09-15
00303620000031PLUNGER FOR PAROJECT-HF02500A1SEPTODONT, INCEGM2016-09-15