Sani-Tip®

FDA UDI

Class II (US FDA UDI)

by Dentsply Professional

Identity

Trade Name: Sani-Tip® FDA UDI
Generic Name: Dental delivery system irrigation handpiece FDA UDI
Device Name: Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Bulk Kit - 1,500 Tips and 250 Sani-Shield® Sleeves. FDA UDI
Model / Reference: 122215 FDA UDI
Description: Sani-Tip® Disposable Air/Water Syringe Tip. Contents: Bulk Kit - 1,500 Tips and 250 Sani-Shield® Sleeves. FDA UDI

Identifiers

Primary DI / UDI-DI: D0031222151 FDA UDI
FDA Product Code: PEM FDA UDI
ECB FDA UDI
GMDN Term: Dental delivery system irrigation handpiece FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4370 FDA UDI
872.4565 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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental delivery system irrigation handpiece Cable/lead/sensor/probe cover, non-sterile

Sani-Tip® by Dentsply Professional — 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 Professional

Sources (1)

FDA UDI e3550e8d-15c1-4b12-8945-4457c7a9bde9 34 fields · synced May 30, 2026