ASPIJECT

GUDID 05713513000010

Self-aspirating dental injection syringe for 1.8 ml standard dental cartridges

Rønvig Dental Manufacturing A/S

Dental anaesthesia syringe, reusable

• Primary Device ID: 05713513000010
• NIH Device Record Key: 90dcc8e2-a6e6-44de-b3c9-eacab96346d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASPIJECT
• Version Model Number: 2055
• Company DUNS: 307549241
• Company Name: Rønvig Dental Manufacturing A/S
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Total Volume: 1.8 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713513000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002168

FDA Product Code

• EJI: Syringe, Cartridge

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[05713513000010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-08-25

Devices Manufactured by Rønvig Dental Manufacturing A/S

• 05713513000089 - CONTA-GUARD: 2022-10-06 200 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 TRIMMER: 2022-10-06 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-IT: 2022-10-06 Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materia
• 05713513000164 - DENTO PREP: 2022-10-05 Dental Micro-blaster for use with aluminium oxide powder.
• 05713513000010 - ASPIJECT: 2018-11-22Self-aspirating dental injection syringe for 1.8 ml standard dental cartridges
• 05713513000010 - ASPIJECT: 2018-11-22 Self-aspirating dental injection syringe for 1.8 ml standard dental cartridges
• 05713513000058 - PAROJECT: 2018-07-06 Intraligamental injection syringe