Osteotom FGL

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref GSD1T.315.018Model 16670

by Edenta Etablissement

Identity

Trade Name: Osteotom FGL EUDAMED
EDENTA FDA UDI
Generic Name: Carbide dental bur, reusable FDA UDI
Device Name: Diamant Instrumente EUDAMED
Osteotome FGL FDA UDI
Model / Reference: 16670 EUDAMED
GSD1T.315.018 EUDAMEDFDA UDI
Description: Osteotome FGL FDA UDI

Identifiers

Primary DI / UDI-DI: E312GSD1T3150181 EUDAMEDFDA UDI
Basic UDI-DI: ++E31216670EL EUDAMED
Unit of Use DI: E312GSD1T315018101 EUDAMED
FDA Product Code: EJL FDA UDI
EMDN Code: Z12110102 DENTAL DRILLS EUDAMED
GMDN Term: Carbide dental bur, reusable FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 872.3240 FDA UDI
Market of Registration: Liechtenstein EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

The Osteotom FGL is a highly reliable and accurate medical device designed for precise bone cutting, providing superior quality and patient safety in various surgical procedures. With its advanced instrumentation and ergonomic design, it enables users to achieve precise cuts with ease, reducing the risk of complications and improving patient outcomes.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	++E31216670EL	Class IIa	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class IIa	Pending data

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Manufacturer

Manufacturer: Edenta Etablissement
EUDAMED SRN: LI-MF-000011937

Sources (2)

EUDAMED 5c476a29-a065-4fb0-aa8f-15a9c08106fe 61 fields · synced Jun 24, 2026
FDA UDI 458b8bf0-c826-4a3a-b3d9-d19a668b7946 33 fields · synced May 30, 2026