devemed

FDA UDI

Class I (US FDA UDI)

by devemed GmbH

Identity

Trade Name: devemed FDA UDI
Generic Name: Dental amalgam condenser, reusable FDA UDI
Device Name: Filling instrument, ball-shaped 1.6 / 2.5 mm F-LINE | SL | double ended FDA UDI
Model / Reference: 1701-80 F FDA UDI
Description: Filling instrument, ball-shaped 1.6 / 2.5 mm F-LINE | SL | double ended FDA UDI

Identifiers

Primary DI / UDI-DI: 04061644022700 FDA UDI
FDA Product Code: EIY FDA UDI
GMDN Term: Dental amalgam condenser, reusable 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 amalgam condenser, reusable

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

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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 c38724ad-a59c-420a-a87e-faa295253941 34 fields · synced May 31, 2026