Plunger For Paroject-Hf02500a1

FDA UDI

Class II (US FDA UDI)

by Septodont

Identity

Trade Name: PLUNGER FOR PAROJECT-HF02500A1 FDA UDI
Generic Name: Dental anaesthesia syringe, reusable FDA UDI
Device Name: Spare part for dental cartridge syringe FDA UDI
Model / Reference: 01N2042 FDA UDI
Description: Spare part for dental cartridge syringe FDA UDI

Identifiers

Primary DI / UDI-DI: 00303620000031 FDA UDI
510(k) Number: K904279 FDA UDI
FDA Product Code: EGM FDA UDI
GMDN Term: Dental anaesthesia syringe, reusable 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

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, reusable

Plunger For Paroject-Hf02500a1 by Septodont — 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

Cleared under the same submission

K904279 also covers:

PAROJECT — Rønvig Dental Manufacturing A/S
PAROJECT — 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

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Manufacturer

Manufacturer: Septodont

Sources (1)

FDA UDI f161a04f-e160-45f4-8359-21ee8312146f 36 fields · synced May 30, 2026