Ovation® C

Basic Information

• Brand Name: Ovation® C
• Primary DI: D807310131001
• Version / Model: 310-131-00
• Catalog Number: 310-131-00
• Company Name: DENTSPLY SIRONA ORTHODONTICS INC.
• Labeler DUNS: 116903307
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-06-26
• Public Version: 6
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: f067439f-0ce4-45ab-ae8e-4404859b7c10
• Distribution End Date: 2020-12-31

Device Description

Ovation® C RT RX 018/UR3 -2T 13A 4M

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NJM	Bracket, ceramic, orthodontic	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58937	Orthodontic bracket, ceramic	A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D807310131001	HIBCC
Unit of Use	D807310131000	HIBCC

Customer Contacts

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