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Sinternit 106h20

FDA UDI

Class II (US FDA UDI)

by Zirkonzahn GmbH

Identity

Trade Name
SINTERNIT 106H20 FDA UDI
Generic Name
Dental bridge, metal-ceramic FDA UDI
Device Name
Content: 1 piece Height: 20 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
MEAS10620 FDA UDI
Description
Content: 1 piece Height: 20 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
D800MEAS10620 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental bridge, metal-ceramic

Sinternit 106h20 by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental bridge, metal-ceramic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zirkonzahn GmbH

Sources (1)

  • FDA UDI 8bee22fb-28fc-4273-860e-404c6609c778 34 fields · synced Jun 8, 2026