AccessGUDID - DEVICE: Nexco (DIVO6489731)

GUDID

Device Identifier (DI) Information

Brand Name: Nexco
Version or Model: 648973
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 648973
Company Name: IVOCLAR VIVADENT AKTIENGESELLSCHAFT

Primary DI Number: DIVO6489731
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 448015938 *Terms of Use

Device Description: SR Nexco Gingiva Opaquer Pink, SR Nexco Paste Gingiva G1 / G2 / G3 / G4 / G5, SR Nexco Paste Intensive Gingiva IG1 / IG2 / IG3 / IG4 / IG5, SR Gel, SR Connect, Various Accessories

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?
38781	Dental prosthesis veneer resin	A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

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: 4fa68687-7e94-4b71-a270-624f5b909cb1
Public Version Date: October 25, 2018
Public Version Number: 1
DI Record Publish Date: September 24, 2018