Rinn®

FDA UDI

Class II (US FDA UDI)

by Dentsply International

Identity

Trade Name: RINN® FDA UDI
Generic Name: Dental x-ray film holder, reusable FDA UDI
Device Name: XCP-DS Fit® Hygiene Kit. Contains: 4 Arms and Rings (1 Anterior, 2 Posterior, 1 Bitewing); 8 XCP-DS FIT® Biteblocks (1 Anterior, 1 Anterior – Thin, 2 Posterior, 2 Horizontal Bitewing, 2 Vertical Bitewing); 50 Universal Sensor Covers FDA UDI
Model / Reference: 559910 FDA UDI
Description: XCP-DS Fit® Hygiene Kit. Contains: 4 Arms and Rings (1 Anterior, 2 Posterior, 1 Bitewing); 8 XCP-DS FIT® Biteblocks (1 Anterior, 1 Anterior – Thin, 2 Posterior, 2 Horizontal Bitewing, 2 Vertical Bitewing); 50 Universal Sensor Covers FDA UDI

Identifiers

Primary DI / UDI-DI: D0035599101 FDA UDI
FDA Product Code: PEM FDA UDI
EGZ FDA UDI
GMDN Term: Dental x-ray film holder, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 FDA UDI
872.1905 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medical equipment/instrument drape, single-use Dental x-ray film holder, reusable

Rinn® by Dentsply International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Dentsply International

Sources (1)

FDA UDI e6c28130-9567-4e51-85b4-9086cb5d5e98 35 fields · synced May 29, 2026