RINN (UDI MK-0500)

Manufactured by Dentsply International Inc.

Data verified against official FDA/EUDAMED records on August 9, 2026

Scannable UDI-DI Representation

Device Regulatory Overview

The RINN (Model/Catalog Number: MK-0500) is a medical device manufactured by Dentsply International Inc.. This product is indexed under FDA Product Code / Category Classification PEM within international Unique Device Identification (UDI) compliance databases.

Technical Specifications

Model Number: MK-0500
Product Code / EMDN: PEM
Device Name: Rinn Universal Sensor Cover, 5 count
Database Sync Date: 2026-08-09 09:02:02

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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Frequently Asked Questions

Who is the primary manufacturer of RINN?

The registered manufacturer of record for RINN is Dentsply International Inc..

What is the Primary UDI-DI identifier for RINN?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MK-0500.

What classification code is assigned to this device?

This device is registered under product classification code PEM.

Similar Classification Devices (PEM)

Other Devices by Dentsply International Inc.

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