Sinternit 95h10

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref MEASxxxx(x)(ww)

by Zirkonzahn GmbH

Identity

Trade Name: SINTERNIT EUDAMED
SINTERNIT 95H10 FDA UDI
Generic Name: Dental bridge, metal-ceramic FDA UDI
Device Name: Dental Metal Blanks EUDAMED
Content: 1 piece Height: 10 mm Sinternit (cobalt-chrome alloy) for the production of single crowns, bridges, bars and telescopic crowns. It is suitable for monolithic restorations as well as structures of up to 14 units for veneering with ceramics. Info: our Sintermetall has a new name: Sinternit. Properties and range of applications remain unchanged FDA UDI
Model / Reference: MEASxxxx(x)(ww) EUDAMED
MEAS9510 FDA UDI
Description: Content: 1 piece Height: 10 mm Sinternit (cobalt-chrome alloy) for the production of single crowns, bridges, bars and telescopic crowns. It is suitable for monolithic restorations as well as structures of up to 14 units for veneering with ceramics. Info: our Sintermetall has a new name: Sinternit. Properties and range of applications remain unchanged FDA UDI

Identifiers

Primary DI / UDI-DI: D800MEASxxxx(x)(ww)0 EUDAMED
D800MEAS9510 FDA UDI
Basic UDI-DI: ++D800COC00200147 EUDAMED
Direct Marketing DI: D800MEASxxxx(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

Yes

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

Sinternit 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 e3668a63-28d1-4e30-8498-4a7674df4fb3 34 fields · synced Jul 26, 2026
EUDAMED ba71ab16-f949-4d02-ae26-3f19cc1c1a20 61 fields · synced Jul 26, 2026