GUDIDData
gudid Primary ID: K85-055-24

MINI OVATION (UDI K85-055-24)

Manufactured by DENTSPLY SIRONA ORTHODONTICS INC.

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for MINI OVATION - Primary ID K85-055-24

Device Regulatory Overview

The MINI OVATION (Model/Catalog Number: K85-055-24) is a medical device manufactured by DENTSPLY SIRONA ORTHODONTICS INC.. This product is indexed under FDA Product Code / Category Classification EJF within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number
K85-055-24
Product Code / EMDN
EJF
Device Name
MINI OVATION Base Rx 022 UL/5-5 CS-BC MHK
Database Sync Date
2026-08-09 09:05:41

Full Regulatory Attributes

🔒 Token Gated
{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}
                            

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Frequently Asked Questions

Who is the primary manufacturer of MINI OVATION?

The registered manufacturer of record for MINI OVATION is DENTSPLY SIRONA ORTHODONTICS INC..

What is the Primary UDI-DI identifier for MINI OVATION?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is K85-055-24.

What classification code is assigned to this device?

This device is registered under product classification code EJF.

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