AccessGUDID - DEVICE: Nacera (EDMC3220WN30930)

GUDID

Device Identifier (DI) Information

Brand Name: Nacera
Version or Model: Pearl 2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3220WN3093
Company Name: DOCERAM medical ceramics GmbH

Primary DI Number: EDMC3220WN30930
Issuing Agency: HIBCC
Commercial Distribution End Date: October 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 537713567 *Terms of Use

Device Description: With Nacera® Pearl you receive a German premium material of highly translucent zirconium oxide for natural-looking restorations. Available in white and in several colored shades, it provides the ideal basis for dental aesthetics. The blanks, each industrially manufactured in Germany using modern equipment, can be processed in most available milling machines and are characterized by their consistent color results and excellent machinability. Finished with a stain-and-glazing technique or using minimal stratification by Cut-Back, Nacera® Pearl is always a reliable quality foundation for monolithic crowns and bridges, as well as abutments and screw retained restorations. Material properties: • Multiple indication: suitable for everything from veneers to wide-span implant-supported bridges (up to 14 units) • Homogeneously shaded blanks ensure high reliability of colors and processes • superior stability: 4 Point Bending Strength 1200 MPa • Natural translucency increases the aesthetics of monolithic restorations • sintering temperature: 1500 °C • Perfect Fit thanks I.F.P. - Instant Fit Process • 3Y-TZP Zirconia, Pure Japanese Quality

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 Humidity: between 20 and 50 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d79b10a9-0d2c-4715-977b-17a382fd9194
Public Version Date: July 24, 2018
Public Version Number: 4
DI Record Publish Date: December 21, 2016