Paroject

FDA UDI

Class II (US FDA UDI)

by Rønvig Dental Manufacturing A/S

Identity

Trade Name: PAROJECT FDA UDI
Generic Name: Dental anaesthesia syringe, intraligamentary FDA UDI
Device Name: Intraligamental injection syringe FDA UDI
Model / Reference: 2018 FDA UDI
Description: Intraligamental injection syringe FDA UDI

Identifiers

Primary DI / UDI-DI: 05713513000058 FDA UDI
510(k) Number: K904279 FDA UDI
FDA Product Code: EGM FDA UDI
GMDN Term: Dental anaesthesia syringe, intraligamentary FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4475 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

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, intraligamentary

Paroject 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, intraligamentary.

OSUNG MND — Osung Mnd Co., Ltd. · Class II
Pike Anesthetic Syringe — PRACTICON, INC. · Class I
SYRINGE-SELF-ASPIRATING — W.H. Holden, Inc. · Class I
ASPIRATING SYRINGE ASTRA TYPE — W.H. Holden, Inc. · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class II
SYRINGE-2CC-LUER-METAL HUB — W.H. Holden, Inc. · Class I
Henry Schein — HENRY SCHEIN, INC. · Class II
ASPIRATING SYRINGE C-W TYPE SS — W.H. Holden, Inc. · Class I

Cleared under the same submission

K904279 also covers:

PAROJECT — Septodont
PLUNGER FOR PAROJECT-HF02500A1 — Septodont

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 367aacb5-e182-487e-b0b9-43b8fc677425 35 fields · synced Jun 8, 2026