Titan 4 95H10

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MEAExxxx(x)(ww)

by Zirkonzahn GmbH

Identity

Trade Name: TITAN 4 EUDAMED
Titan 4 95H10 FDA UDI
Generic Name: Dental bridge, metal-ceramic FDA UDI
Device Name: Dental Metal Blanks EUDAMED
Content: 1 piece Height: 10 mm Titanium with toughness degree 4 (ASTM) for metal frameworks for veneering with ceramics as well as for bar and implant constructions FDA UDI
Model / Reference: MEAExxxx(x)(ww) EUDAMED
MEAE0110 FDA UDI
Description: Content: 1 piece Height: 10 mm Titanium with toughness degree 4 (ASTM) for metal frameworks for veneering with ceramics as well as for bar and implant constructions FDA UDI

Identifiers

Primary DI / UDI-DI: D800MEAExxxx(x)(ww)0 EUDAMED
D800MEAE0110 FDA UDI
Basic UDI-DI: ++D800TIT001001MN EUDAMED
Direct Marketing DI: D800MEAExxxx(x)(ww)0 EUDAMED
FDA Product Code: EJH FDA UDI
EMDN Code: Q01020602 COMBINED DENTAL PROSTHESES EUDAMED
GMDN Term: Dental bridge, metal-ceramic FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 872.3710 FDA UDI
Market of Registration: Italy EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

Yes

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

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

Yes

FDA UDI

Category: Dental bridge, metal-ceramic

Titan 4 95H10 by Zirkonzahn GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Dental bridge, metal-ceramic.

Prodent — Prodent Dental Technology (Shenzhen) Co., Ltd. · Class II
Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
Denture, Restoration — ACESO DENTAL LABORATORY COMPANY LIMITED · N
STRAUMANN CARES SCREW RETAINED BARS/BRIDGE — Institut Straumann SA · Class II
Base metal alloy — Institut Straumann SA · Class II
Denture, restoration — Modern Dental Laboratory (DG) Co., Ltd. · N
CAD/CAM Pontic Zirconia — Beijing Yingguan Dental Technology Co., Ltd. · N
Base metal alloy — Institut Straumann SA · Class II

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 II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Zirkonzahn GmbH

Sources (2)

FDA UDI 3ec585a2-18f6-4377-b86d-e8dedbaf5761 34 fields · synced Jul 9, 2026
EUDAMED 74fb2697-b352-4250-ad0a-988c2a9de65c 61 fields · synced Jul 9, 2026