gudid
Primary ID: K85-055-23
MINI OVATION (UDI K85-055-23)
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 K85-055-23
Device Regulatory Overview
The MINI OVATION (Model/Catalog Number: K85-055-23) 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
- K85-055-23
- Product Code / EMDN
- EJF
- Device Name
- MINI OVATION Base Rx 022 UL/5-5 CS HK
- 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
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)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 K85-055-23.
What classification code is assigned to this device?
This device is registered under product classification code EJF.
Similar Classification Devices (EJF)
Other Devices by DENTSPLY SIRONA ORTHODONTICS INC.
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint