AccessGUDID - DEVICE: OVC™ One Visit Crown (09421031790899)

GUDID

Device Identifier (DI) Information

Brand Name: OVC™ One Visit Crown
Version or Model: OVC Starter Kit A2 US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OVC Starter Kit A2 US
Company Name: RHONDIUM LIMITED

Primary DI Number: 09421031790899
Issuing Agency: GS1
Commercial Distribution End Date: September 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 595078345 *Terms of Use

Device Description: The Starter Kit consists of a set of 40 OVCs in tooth shade A2 - one each for 8 tooth types, upper and lower molar and premolars, in five sizes for each tooth type individually packaged. Each OVC is packaged with 4 x OVC Wedges, a Selector Key and an OVC Replica. Each kit includes an accessory kit - a convenience kit for clinicians containing a procedural aids.

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:	Yes
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?
61718	Preformed dental crown, permanent	A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is made of ceramic and polymer materials and may require minimal fashioning in situ during restorative work. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure (e.g. disposable prosthesis gauge).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143694	000

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 Temperature: between 1 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Extra small, small, medium, large, extra large

Device Record Status

Public Device Record Key: 7bb0b58c-2748-4b70-ad22-62423a7751f4
Public Version Date: November 26, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016