gudid
Primary ID: 861-131
ImpressaChrome (UDI 861-131)
Manufactured by AMERICAN ORTHODONTICS CORPORATION
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for ImpressaChrome - Primary ID 861-131
Device Regulatory Overview
The ImpressaChrome (Model/Catalog Number: 861-131) is a medical device manufactured by AMERICAN ORTHODONTICS CORPORATION. This product is indexed under FDA Product Code / Category Classification ELW within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 861-131
- Product Code / EMDN
- ELW
- Device Name
- SUPPLIES-IMPRESSA/CHROME ALGINATE STARTER KIT
- Database Sync Date
- 2026-08-09 09:00:44
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 ImpressaChrome?
The registered manufacturer of record for ImpressaChrome is AMERICAN ORTHODONTICS CORPORATION.
What is the Primary UDI-DI identifier for ImpressaChrome?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 861-131.
What classification code is assigned to this device?
This device is registered under product classification code ELW.
Similar Classification Devices (ELW)
Other Devices by AMERICAN ORTHODONTICS CORPORATION
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