Nacera Pearl Shaded 16+2

FDA UDI

Class II (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name: Nacera Pearl Shaded 16+2 FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering. FDA UDI
Model / Reference: 98.3x18 C1 FDA UDI
Description: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering. FDA UDI

Identifiers

Catalog Number: 3271309818 FDA UDI
Primary DI / UDI-DI: EDDI32713098181 FDA UDI
FDA Product Code: EIH FDA UDI
GMDN Term: Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.6660 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 98.3 Millimeter FDA UDI
Height — 18 Millimeter FDA UDI

Category: Dental appliance fabrication material, ceramic

Nacera Pearl Shaded 16+2 by Dental Direkt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Dental Direkt GmbH

Sources (1)

FDA UDI e185d9dc-aa0b-444b-9e09-98f336952f36 36 fields · synced Jun 8, 2026