Obtura Needles, 25 ga.

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 823-635

by Young Innovations Inc

Identity

Trade Name: Obtura Needles, 25 ga. EUDAMED
Obtura Spartan FDA UDI
Generic Name: Dental material injection cannula, single-use FDA UDI
Device Name: Obtura Needles, 25 ga. EUDAMEDFDA UDI
Model / Reference: 823-635 EUDAMEDFDA UDI
Description: Obtura Needles, 25 ga. FDA UDI

Identifiers

Catalog Number: 823-635 FDA UDI
Primary DI / UDI-DI: 10843471100377 EUDAMED
00843471100370 FDA UDI
Basic UDI-DI: B-10843471100377 EUDAMED
FDA Product Code: EKR FDA UDI
EMDN Code: Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term: Dental material injection cannula, single-use FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 872.4565 FDA UDI
Market of Registration: Portugal EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

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

Yes

FDA UDI

Category: Dental appliance fabrication material, ceramic

Obtura Needles, 25 ga. by Young Innovations, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDD	B-10843471100377	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Young Innovations Inc
EUDAMED SRN: US-MF-000017796
Authorised Representative: Young Microbrush Ireland Ltd IE-AR-000011249

Sources (2)

EUDAMED bb646719-5124-40b1-ad96-1589b0e6fc70 61 fields · synced Jul 9, 2026
FDA UDI 2a608e11-ba16-4ad5-b08b-3e95398ce419 35 fields · synced May 30, 2026