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: FASTab™ Bitewing Holder & Uni-Grip 360 Holder. Contains: 100 FASTab™ Bitewing Holders, 25 Uni-Grip® 360 Sensor Holders, 125 Size 1 Rinn® Tight Sensor Covers and 1 Positioning Arm and Ring FDA UDI
Model / Reference: 550147 FDA UDI
Description: FASTab™ Bitewing Holder & Uni-Grip 360 Holder. Contains: 100 FASTab™ Bitewing Holders, 25 Uni-Grip® 360 Sensor Holders, 125 Size 1 Rinn® Tight Sensor Covers and 1 Positioning Arm and Ring FDA UDI

Identifiers

Primary DI / UDI-DI: D0035501471 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

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental x-ray film holder, reusable Cable/lead/sensor/probe cover, non-sterile

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

Similar devices

Also classified as Cable/lead/sensor/probe cover, non-sterile.

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Pinnacle X-Ray Sensor Sheaths — METREX RESEARCH · Class II
Pinnacle X-Ray Sensor Sheath — METREX RESEARCH · Class II
Sani-Tip® — Dentsply Professional · Class I
Disposa-Shield® — Dentsply Professional · Class I
Sani-Tip® — Dentsply Professional · Class I

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 47621a9a-8fd5-4017-b075-605da400029c 35 fields · synced Jun 8, 2026