gudid
Primary ID: K189-055-36
IN-OVATION R (UDI K189-055-36)
Manufactured by DENTSPLY SIRONA ORTHODONTICS INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for IN-OVATION R - Primary ID K189-055-36
Device Regulatory Overview
The IN-OVATION R (Model/Catalog Number: K189-055-36) 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
- K189-055-36
- Product Code / EMDN
- EJF
- Device Name
- IN-OVATION R RNC 022 UL/5-5 CS-BC HK
- Database Sync Date
- 2026-08-09 09:05:41
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of IN-OVATION R?
The registered manufacturer of record for IN-OVATION R is DENTSPLY SIRONA ORTHODONTICS INC..
What is the Primary UDI-DI identifier for IN-OVATION R?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is K189-055-36.
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.
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