AccessGUDID - DEVICE: VITA CAD-Waxx (J017EC4CW40100)

GUDID

Device Identifier (DI) Information

Brand Name: VITA CAD-Waxx
Version or Model: EC4CW4010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft

Primary DI Number: J017EC4CW40100
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315165357 *Terms of Use

Device Description: VITA CAD-Waxx for inLab®, CW-40/15, 10 pcs.

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?
16189	Dental casting wax	A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGD	WAX, DENTAL, INTRAORAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: a65aeb06-6858-4cf2-94b3-8a1b149fe37f
Public Version Date: March 19, 2024
Public Version Number: 1
DI Record Publish Date: March 11, 2024