AccessGUDID - DEVICE: V-Print Try-In (E22160491)

GUDID

Device Identifier (DI) Information

Brand Name: V-Print Try-In
Version or Model: 6049
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6049
Company Name: VOCO GmbH

Primary DI Number: E22160491
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316699578 *Terms of Use

Device Description: V-Print Try-In is a light-curing resin for the generative manufacture of try-ins for full and partial dentures using CAD/CAM technology.

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?
57949	Dental guided surgery reference plate	A non-sterile device in the form of a plate designed for the fabrication of custom-made scan and surgical dental implant templates used by a dentist during the first stage of a guided dental implantation procedure (i.e., drilling holes in the jawbone for implant placement/fixation). It is a plastic plate of a predefined shape and hole configuration for placement of dental guided surgery reference pins to form a link between a chairside cone beam computerized tomography (CBCT) scan and a coordinate system for dental laboratory fabrication of the scan template (used to scan the patient) and then the surgical dental implant template. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EEA	Plate, Base, Shellac

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: 91531362-55fe-492f-92bc-33040465bf88
Public Version Date: June 24, 2020
Public Version Number: 1
DI Record Publish Date: June 16, 2020