gudid
Primary ID: 4c
Perma Soft Denture Reliner (UDI 4c)
Manufactured by PERMA LABORATORIES LLC
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Perma Soft Denture Reliner - Primary ID 4c
Device Regulatory Overview
The Perma Soft Denture Reliner (Model/Catalog Number: 4c) is a medical device manufactured by PERMA LABORATORIES LLC. This product is indexed under FDA Product Code / Category Classification EBP within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 4c
- Product Code / EMDN
- EBP
- Device Name
- A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
- Database Sync Date
- 2026-08-09 09:49:33
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 Perma Soft Denture Reliner?
The registered manufacturer of record for Perma Soft Denture Reliner is PERMA LABORATORIES LLC.
What is the Primary UDI-DI identifier for Perma Soft Denture Reliner?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 4c.
What classification code is assigned to this device?
This device is registered under product classification code EBP.
Similar Classification Devices (EBP)
Other Devices by PERMA LABORATORIES LLC
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