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DD Ti-Base 2CUT

FDA UDI

Class II (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name
DD Ti-Base 2CUT FDA UDI
Generic Name
Dental implant suprastructure, permanent, preformed FDA UDI
Device Name
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. The Dental Direkt Ti-Base 2CUT serves as a titanium bonding base for individualized crown and abutment restorations. The titanium bonding bases are available for various implant systems and consist of a prefabricated implant connection (interface), screw channel, a circumferential platform for designing the emergence profile, an anti-rotation guard that serves to align the abutment in the vertical axis, and a shortenable cylinder for customized patient restorations. FDA UDI
Model / Reference
DFX 38 Set FDA UDI
Description
DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. The Dental Direkt Ti-Base 2CUT serves as a titanium bonding base for individualized crown and abutment restorations. The titanium bonding bases are available for various implant systems and consist of a prefabricated implant connection (interface), screw channel, a circumferential platform for designing the emergence profile, an anti-rotation guard that serves to align the abutment in the vertical axis, and a shortenable cylinder for customized patient restorations. FDA UDI

Identifiers

Catalog Number
DDDFXKL38S FDA UDI
Primary DI / UDI-DI
EDDIDDDFXKL38S1 FDA UDI
FDA Product Code
NHA FDA UDI
GMDN Term
Dental implant suprastructure, permanent, preformed FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Dental implant suprastructure, permanent, preformed

DD Ti-Base 2CUT by Dental Direkt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental implant suprastructure, permanent, preformed.

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 4f85189a-29f2-42b5-bd69-0acbd87618ff 36 fields · synced May 31, 2026