Sinternit Postcore 98h10

FDA UDI

Class II (US FDA UDI)

by Zirkonzahn GmbH

Identity

Trade Name: SINTERNIT POSTCORE 98H10 FDA UDI
Generic Name: Dental bridge, metal-ceramic FDA UDI
Device Name: Content: 1 piece Height: 10 mm Sinternit (cobalt-chrome alloy) especially conceived for the production of dowels. Veneering with ceramic possible. FDA UDI
Model / Reference: MEAU9810 FDA UDI
Description: Content: 1 piece Height: 10 mm Sinternit (cobalt-chrome alloy) especially conceived for the production of dowels. Veneering with ceramic possible. FDA UDI

Identifiers

Primary DI / UDI-DI: D800MEAU9810 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

Sinternit Postcore 98h10 by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — 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 (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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Zirkonzahn GmbH

Sources (1)

FDA UDI d1aa2ab0-c964-4345-a952-6639518782a6 34 fields · synced May 30, 2026