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DD Implant Screw

FDA UDI

Class II (US FDA UDI)

by Dental Direkt GmbH

Identity

Trade Name
DD Implant Screw 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 Implant Screw is an accessory for the DD Solid Connect® products and can only be used in combination with them. The Dental Direkt Implant Screw is used to fix the abutment, ti-base or scanbody to the implant (two-part implant system). The Dental Direkt Implant Screw is available for different implant systems. FDA UDI
Model / Reference
ZTA 35/45/57 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 Implant Screw is an accessory for the DD Solid Connect® products and can only be used in combination with them. The Dental Direkt Implant Screw is used to fix the abutment, ti-base or scanbody to the implant (two-part implant system). The Dental Direkt Implant Screw is available for different implant systems. FDA UDI

Identifiers

Catalog Number
DDZTAIS57 FDA UDI
Primary DI / UDI-DI
EDDIDDZTAIS571 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 Implant Screw 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 d0fafc45-3792-4939-ba13-b495320bbf91 36 fields · synced May 31, 2026