AccessGUDID - DEVICE: inCoris & CEREC (E27665357560)

GUDID

Device Identifier (DI) Information

Brand Name: inCoris & CEREC
Version or Model: 6535756
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SIRONA Dental Systems GmbH

Primary DI Number: E27665357560
Issuing Agency: HIBCC
Commercial Distribution End Date: October 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 340306351 *Terms of Use

Device Description: inCoris Intro-Kit N consists of 1 pcs of: 6135458 BLOCK 40/15 ZI F2 6135854 BLOCK 40/19 ZI F2 6122753 BLOCK 40/19 ZI F0.5 6339456 Block inCoris TZI 40/19 6605773 CEREC Blocs C In BL2 6449990 CEREC Blocs C In A1 6605781 CEREC Blocs C In A2 6605799 CEREC Blocs C In A3 6605807 CEREC Blocs C In A3,5 6605815 CEREC Blocs C In A4 6480433 Block inCoris TZI C mono L 20/19 A1 6480441 Block inCoris TZI C mono L 20/19 A2 6480458 Block inCoris TZI C mono L 20/19 A3 6480466 Block inCoris TZI C mono L 20/19 A3,5 6480474 Block inCoris TZI C mono L 20/19 A4

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?
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
No Device Sizes

Device Record Status

Public Device Record Key: 0885902d-cb7c-46e0-ada4-11ea6940c427
Public Version Date: October 16, 2023
Public Version Number: 5
DI Record Publish Date: September 16, 2016