ASPIJECT Active Compact

FDA UDI

Class II (US FDA UDI)

by Rønvig Dental Manufacturing A/S

Identity

Trade Name: ASPIJECT Active Compact FDA UDI
Generic Name: Dental anaesthesia syringe, reusable FDA UDI
Device Name: Aspirating dental injection syringe for 1.8 ml cartridges FDA UDI
Model / Reference: 2041 FDA UDI
Description: Aspirating dental injection syringe for 1.8 ml cartridges FDA UDI

Identifiers

Primary DI / UDI-DI: 05713513001185 FDA UDI
FDA Product Code: EJI FDA UDI
GMDN Term: Dental anaesthesia syringe, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6770 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Total Volume — 1.8 Milliliter FDA UDI

Category: Dental anaesthesia syringe, reusable

ASPIJECT Active Compact by Rønvig Dental Manufacturing A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental anaesthesia syringe, reusable.

Septodont — A.Titan Instruments · Class II
BENCO — BENCO DENTAL SUPPLY CO. · Class II
Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
A. Titan Instruments — A.Titan Instruments · Class II
Dentapen Protective Sleeve — JUVAPLUS SA · Class II
Henry Schein — HENRY SCHEIN, INC. · Class II
Dentapen Injector — JUVAPLUS SA · Class II
Integra® Jarit® — Integra LifeSciences Production Corporation · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Rønvig Dental Manufacturing A/S

Sources (1)

FDA UDI 9f17f514-c2b5-4e36-ace9-89ec2f2635f1 34 fields · synced May 30, 2026