EMS Threaded Tip CPR-4E

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 932-004

by Young Innovations Inc

Identity

Trade Name: EMS Threaded Tip CPR-4E EUDAMED
Obtura Spartan FDA UDI
Generic Name: Dental ultrasonic surgical system handpiece tip FDA UDI
Device Name: EMS Threaded Tip CPR-4E EUDAMED
EMS Threaded Tip CPR-4E FDA UDI
Model / Reference: 932-004 EUDAMEDFDA UDI
Description: EMS Threaded Tip CPR-4E FDA UDI

Identifiers

Catalog Number: 932-004 FDA UDI
Primary DI / UDI-DI: 10843471100803 EUDAMED
00843471100806 FDA UDI
Basic UDI-DI: B-10843471100803 EUDAMED
FDA Product Code: ELC FDA UDI
EMDN Code: Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term: Dental ultrasonic surgical system handpiece tip FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 872.4850 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental appliance fabrication material, ceramic

EMS Threaded Tip CPR-4E 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-10843471100803	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 33404b38-1322-4d95-9cbb-57d9addf685c 61 fields · synced Jul 29, 2026
FDA UDI 3f0ee644-b4c5-43cb-99d5-8fe6c22b1507 35 fields · synced May 30, 2026