AccessGUDID - DEVICE: Nacera (EDMC35683039130)

GUDID

Device Identifier (DI) Information

Brand Name: Nacera
Version or Model: Pearl Natural B2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3568303913
Company Name: DOCERAM medical ceramics GmbH

Primary DI Number: EDMC35683039130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 537713567 *Terms of Use

Device Description: 3Y/5Y-TZP zirconium oxide, pre-sintered white fired condition, high translucent, translucency gradient, multi-shade. Suitable for single crowns, inlays, onlays, veneers and bridges up to 16 units. Bi-axial bending strength from 1,100 – 1,350 MPa.

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
Storage Environment Temperature: between 10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 16 Millimeter

Device Record Status

Public Device Record Key: 42e91deb-790e-420f-b96a-999daf00389c
Public Version Date: April 22, 2021
Public Version Number: 1
DI Record Publish Date: April 14, 2021