Helmut Zepf

FDA UDI

Class I (US FDA UDI)

by Helmut Zepf Medizintechnik GmbH

Identity

Trade Name: HELMUT ZEPF FDA UDI
Generic Name: Dental elevator, tooth/root FDA UDI
Device Name: ELEVTOR; ROOT ELEVATOR F. ROOTS OF TEETH BARRY, ROOT ELEVATOR, FIG-151, (HU 1195), AS PER SAMPLE FDA UDI
Model / Reference: KS17.151 FDA UDI
Description: ELEVTOR; ROOT ELEVATOR F. ROOTS OF TEETH BARRY, ROOT ELEVATOR, FIG-151, (HU 1195), AS PER SAMPLE FDA UDI

Identifiers

Catalog Number: KS17.151 FDA UDI
Primary DI / UDI-DI: EZPFKS171510 FDA UDI
FDA Product Code: EMJ FDA UDI
GMDN Term: Dental elevator, tooth/root FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.4565 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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

Category: Dental elevator, tooth/root

Helmut Zepf by Helmut Zepf Medizintechnik GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Dental elevator, tooth/root.

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OSUNG MND — Osung Mnd Co., Ltd. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I
Power Dental USA — Power Dental USA, Inc. · Class I
Paul Banditt — Terlain Enterprises, Inc. · Class I
Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Helmut Zepf Medizintechnik GmbH

Sources (1)

FDA UDI 4bc5d672-e6d9-4085-a878-9f49a8029a6a 35 fields · synced Jun 6, 2026