AccessGUDID - DEVICE: Nacera Pearl Shaded 16+2 (EDDI32653024241)

GUDID

Device Identifier (DI) Information

Brand Name: Nacera Pearl Shaded 16+2
Version or Model: 24x24x24 A3.5
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3265302424
Company Name: Dental Direkt GmbH

Primary DI Number: EDDI32653024241
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 313214171 *Terms of Use

Device Description: The Nacera® Pearl Shaded 16+2 zirconium dioxide milling blanks made of yttrium-stabilized zirconium dioxide (3Y-TZP) are suitable for dental applications of type II, class 5 in accordance with DIN EN ISO 6872 and they fulfill their material-specific requirements after specified final sintering.

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:	No
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?
16187	Dental appliance fabrication material, ceramic	A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIH	Powder, Porcelain

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Millimeter
Height: 24 Millimeter
Width: 24 Millimeter

Device Record Status

Public Device Record Key: f1f22bf6-b6d1-4962-87d3-c562585e262b
Public Version Date: June 05, 2024
Public Version Number: 1
DI Record Publish Date: May 28, 2024