← Back to catalogue

DD Prefab

FDA UDI

Class II (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name
DD Prefab 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 Prefab blanks are prefabricated components for the metal-cutting production of individualized and one-piece abutments using CAD/CAM technology. The Dental Direkt Prefab blanks are available for various implant systems and consist of a prefabricated implant connection (interface), screw channel, a retaining element for fastening in the milling machine and a groove for aligning the direction of rotation (axis of rotation). FDA UDI
Model / Reference
DEV 36 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 Prefab blanks are prefabricated components for the metal-cutting production of individualized and one-piece abutments using CAD/CAM technology. The Dental Direkt Prefab blanks are available for various implant systems and consist of a prefabricated implant connection (interface), screw channel, a retaining element for fastening in the milling machine and a groove for aligning the direction of rotation (axis of rotation). FDA UDI

Identifiers

Catalog Number
DDDEVPF36S FDA UDI
Primary DI / UDI-DI
EDDIDDDEVPF36S1 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 Prefab 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

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

Manufacturer

Manufacturer
Dental Direkt GmbH

Sources (1)

  • FDA UDI 40761c68-1c2b-48fb-ba56-592b12ec85ec 36 fields · synced Jun 6, 2026