devemed

FDA UDI

Class I (US FDA UDI)

by devemed GmbH

Identity

Trade Name: devemed FDA UDI
Generic Name: Dental elevator, tooth/root FDA UDI
Device Name: PIVOT POINT-Root elevator # 85 U mod. 3.5 mm, bent down, serrated F-LINE | PH FDA UDI
Model / Reference: 675-22 F FDA UDI
Description: PIVOT POINT-Root elevator # 85 U mod. 3.5 mm, bent down, serrated F-LINE | PH FDA UDI

Identifiers

Primary DI / UDI-DI: 04061644032679 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

devemed by devemed GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental elevator, tooth/root.

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ELEVATOR #107 — W.H. Holden, Inc. · Class I
Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
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

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: devemed GmbH

Sources (1)

FDA UDI 49a5bf8b-7e97-494f-9edf-e601eac05307 34 fields · synced May 31, 2026