AccessGUDID - DEVICE: OVC3 Hybrid (09421031796181)

GUDID

Device Identifier (DI) Information

Brand Name: OVC3 Hybrid
Version or Model: OVC3 Hybrid FDI 16.17 XL : USA 2-3 XL A3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9421031796181
Company Name: RHONDIUM LIMITED

Primary DI Number: 09421031796181
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 595078345 *Terms of Use

Device Description: Package contains an OVC Hybrid in Shade A3 for tooth number FDI 16.17 XL : USA 2-3 XL A3 (Extra-Large) 2 x OVC Wedges, 2 x Stretch Wedges, 1 x Selector Key, 2 x OVC3 Matrix Band and 1 x OVC Replica

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:	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?
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-Large

Device Record Status

Public Device Record Key: 2c7403fd-ad46-4837-aebd-8c1087184e8e
Public Version Date: March 21, 2019
Public Version Number: 1
DI Record Publish Date: March 13, 2019