Endo Assist Teal

FDA UDI

Class I (US FDA UDI)

by Zirc Dental Products, Inc.

Identity

Trade Name: Endo Assist Teal FDA UDI
Generic Name: Surgical instrument guard, reusable FDA UDI
Device Name: "Built-in millimeter gauge measures files and positions rubber stopper Right or left hand use Small and large rings are included to accommodate most finger sizes Flat bottom enables the Endo Assist to stand freely on its own Comes with 12 disposable foam inserts Foam cleans and holds files Designed to slide into side of the Endo Guards Dimensions: 1-1/2"" x 1-3/4"" x 1-5/8"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI
Model / Reference: 50Z460J-PAT FDA UDI
Description: "Built-in millimeter gauge measures files and positions rubber stopper Right or left hand use Small and large rings are included to accommodate most finger sizes Flat bottom enables the Endo Assist to stand freely on its own Comes with 12 disposable foam inserts Foam cleans and holds files Designed to slide into side of the Endo Guards Dimensions: 1-1/2"" x 1-3/4"" x 1-5/8"" Autoclavable up to 136°C/275°F Washer-disinfect" FDA UDI

Identifiers

Primary DI / UDI-DI: 00840161308757 FDA UDI
FDA Product Code: FSM FDA UDI
GMDN Term: Surgical instrument guard, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 38.1 Millimeter FDA UDI
Width — 44.5 Millimeter FDA UDI
Height — 41.3 Millimeter FDA UDI

Category: Surgical instrument guard, reusable

Endo Assist Teal by Zirc Dental Products, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Zirc Dental Products, Inc.

Sources (1)

FDA UDI 56fa777d-ea8d-4a20-8a52-fcfacebebc0c 34 fields · synced May 30, 2026