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Calaject

FDA UDI

Class II (US FDA UDI)

by Rønvig Dental Manufacturing A/S

Identity

Trade Name
CALAJECT FDA UDI
Generic Name
Dental computer assisted anaesthesia injection unit FDA UDI
Device Name
Computer-assisted dental injection syringe FDA UDI
Model / Reference
2118 FDA UDI
Description
Computer-assisted dental injection syringe FDA UDI

Identifiers

Primary DI / UDI-DI
05713513000942 FDA UDI
FDA Product Code
EJI FDA UDI
GMDN Term
Dental computer assisted anaesthesia injection unit 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental computer assisted anaesthesia injection unit

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

Similar devices

Also classified as Dental computer assisted anaesthesia injection unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Rønvig Dental Manufacturing A/S

Sources (1)

  • FDA UDI d81d557f-0a97-4102-b52a-72ab69e3781e 34 fields · synced Jun 1, 2026