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Endo-Express

FDA UDI

Class I (US FDA UDI)

by Essential Dental Systems, Inc.

Identity

Trade Name
Endo-Express FDA UDI
Generic Name
Dental power tool handpiece motorless component FDA UDI
Device Name
Endo-Express Reciprocating Handpiece FDA UDI
Model / Reference
5500-00 FDA UDI
Description
Endo-Express Reciprocating Handpiece FDA UDI

Identifiers

Catalog Number
5500-00 FDA UDI
Primary DI / UDI-DI
00766054001188 FDA UDI
FDA Product Code
EGS FDA UDI
GMDN Term
Dental power tool handpiece motorless component FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental power tool handpiece motorless component

Endo-Express by Essential Dental Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental power tool handpiece motorless component.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Essential Dental Systems, Inc.

Sources (1)

  • FDA UDI a5a6e6fb-4338-481f-b11e-96741ba9a509 35 fields · synced Jun 8, 2026