Sintermetall 95H16

FDA UDI

Class II (US FDA UDI)

by Zirkonzahn GmbH

Identity

Trade Name: Sintermetall 95H16 FDA UDI
Generic Name: Dental bridge, metal-ceramic FDA UDI
Device Name: Content: 1 piece Height: 16 mm Sinter metal (chrome-cobalt alloy) for metal frameworks for veneering with ceramics FDA UDI
Model / Reference: MEAD0616 FDA UDI
Description: Content: 1 piece Height: 16 mm Sinter metal (chrome-cobalt alloy) for metal frameworks for veneering with ceramics FDA UDI

Identifiers

Primary DI / UDI-DI: D800MEAD0616 FDA UDI
FDA Product Code: EJH FDA UDI
GMDN Term: Dental bridge, metal-ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3710 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

Yes

FDA UDI

Category: Dental bridge, metal-ceramic

Sintermetall 95H16 by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental bridge, metal-ceramic.

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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 (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 II	Pending data

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Manufacturer

Manufacturer: Zirkonzahn GmbH

Sources (1)

FDA UDI d8bfc040-4a92-4212-96e3-47c4aa9b36cb 34 fields · synced May 31, 2026