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CediTEC DB

FDA UDI

Class II (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name
CediTEC DB FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
CediTEC DB polymer milling blanks are intended for the fabrication of restorations. FDA UDI
Model / Reference
Disc pink 30 mm FDA UDI
Description
CediTEC DB polymer milling blanks are intended for the fabrication of restorations. FDA UDI

Identifiers

Catalog Number
6195 FDA UDI
Primary DI / UDI-DI
EDDI61951 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Height — 30 Millimeter FDA UDI
Outer Diameter — 98.5 Millimeter FDA UDI

Category: Dental appliance fabrication material, thermoplastic

CediTEC DB by Dental Direkt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dental Direkt GmbH

Sources (1)

  • FDA UDI 6a0d8ada-49fb-4b28-820a-7d6a61810bea 35 fields · synced Jun 8, 2026