TrollFoil

FDA UDIEUDAMED

Class I (US FDA UDI)

by Directa AB

Identity

Trade Name: TrollFoil FDA UDI
Generic Name: Dental articulator FDA UDI
Model / Reference: Mini Blue FDA UDI

Identifiers

Catalog Number: 12000402 FDA UDI
Primary DI / UDI-DI: 17310230005226 FDA UDI
FDA Product Code: EFH FDA UDI
GMDN Term: Dental articulator FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6140 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental articulator

TrollFoil by Directa AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental articulator.

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W.O.W.™ — PREMIER DENTAL PRODUCTS COMPANY · Class I
Denar Mark 330 Articulator — WHIP-MIX CORP. · Class I
HANDY IIM — SHOFU DENTAL CORP. · Class I
Stratos 300 Grundausstattung — IVOCLAR VIVADENT AKTIENGESELLSCHAFT · Class I
MA2340 W/STRAPS — WHIP-MIX CORP. · Class I
Hanau Wide-Vue Articulator — WHIP-MIX CORP. · Class I
2240 Q Articulator — WHIP-MIX CORP. · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Directa AB

Sources (2)

FDA UDI 78a3a19b-7d7c-4b3a-8631-5623fe0723c1 33 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 18, 2026