AccessGUDID - DEVICE: DD Prefab MDK (EDDIMDKZBCPF41S1)

GUDID

Device Identifier (DI) Information

Brand Name: DD Prefab MDK
Version or Model: ZBC 41 Set
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MDKZBCPF41S
Company Name: Dental Direkt GmbH

Primary DI Number: EDDIMDKZBCPF41S1
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 Prefab MDK blanks are prefabricated components for the metal-cutting production of individualized and one-piece abutments using CAD/CAM technology. The Dental Direkt Prefab MDK 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).

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: 4.1mm; Compatible with Zimmer Biomet 3i Certain® system

Device Record Status

Public Device Record Key: fc3fe6ef-3dca-43d6-a42e-1dcc20598398
Public Version Date: April 01, 2024
Public Version Number: 1
DI Record Publish Date: March 22, 2024