AccessGUDID - DEVICE: DD Implant Screw (EDDIDDCCAIS431)

GUDID

Device Identifier (DI) Information

Brand Name: DD Implant Screw
Version or Model: CCA 33/38/43
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DDCCAIS43
Company Name: Dental Direkt GmbH

Primary DI Number: EDDIDDCCAIS431
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313214171 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44879	Dental implant suprastructure, permanent, preformed	A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NHA	Abutment, Implant, Dental, Endosseous

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Interface: 3.3mm and 3.8mm and 4.3mm; Compatible with Altatec Camlog® system

Device Record Status

Public Device Record Key: 7bf11881-e3f8-49a9-8bc9-633afc3e36ca
Public Version Date: October 10, 2023
Public Version Number: 1
DI Record Publish Date: October 02, 2023