OVC™ One Visit Crown

Basic Information

• Brand Name: OVC™ One Visit Crown
• Primary DI: 09421031790905
• Version / Model: OVC Starter Kit A3 US
• Catalog Number: OVC Starter Kit A3 US
• Company Name: RHONDIUM LIMITED
• Labeler DUNS: 595078345
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2018-11-26
• Public Version Status: Update
• Public Device Record Key: 0159ceff-da91-486f-a27c-7440270aae98
• Distribution End Date: 2017-09-01

Device Description

The Starter Kit consists of a set of 40 OVCs in tooth shade A3 - 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

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBF	Material, Tooth Shade, Resin	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09421031790905	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K143694	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Extra small, small, medium, large, extra large

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 25 Degrees Celsius