AccessGUDID - DEVICE: DD Bio ZX² monolith zero (EDDILZP0031)

GUDID

Device Identifier (DI) Information

Brand Name: DD Bio ZX² monolith zero
Version or Model: B4+
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: LZP003
Company Name: Dental Direkt GmbH

Primary DI Number: EDDILZP0031
Issuing Agency: HIBCC
Commercial Distribution End Date: April 12, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 313214171 *Terms of Use

Device Description: DD Bio ZX² monolith zero Liquids are indicated for coloring of pre-sintered Dental Direkt zirconia milling blanks for the manufacture of dental restorations.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
62110	Dental prosthesis dye	A colouring intended to be used to stain a dental prosthesis (e.g., crown, bridge) before insertion in the patient to achieve a colour to match existing dentition. It is a mixture of inorganic chemicals typically used during the prosthesis manufacturing process. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIH	Powder, Porcelain

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150196	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 30 Milliliter

Device Record Status

Public Device Record Key: eaf4d3d2-fea8-4b4d-8ae3-bdd74e58afec
Public Version Date: December 08, 2025
Public Version Number: 4
DI Record Publish Date: October 05, 2016