Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020989

FEI Number

3020989

Entity Name

ENGLE DENTAL SYSTEMS, LLC

City/State/Country

Hillsboro, OR, US

Establishment Address

7205 NE Evergreen Pkwy Bldg E # 100, Hillsboro, OR 97124, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ENGLE DENTAL SYSTEMS, LLC (Owner Number: 10047558)

Owner / Operator Contact Address

7205 NE Evergreen PKWY, Bldg. B #100, Hillsboro, OR 97124, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

E300 Chair E300 Wide E300 Narrow E300 Traverse E300 Traverse Narrow ENGLE 320 PACKAGE ENGLE 2200 PACKAGE ENGLE 310 PACKAGE ENGLE 360 PACKAGE WITH ENGLE 300 CHAIR WITH 360 LEFT/RIGHT DELIVERY ENGLE 1200 PACKAGE ENGLE 360 PACKAGE ENGLE 310 PACKAGE WITH ENGLE 300 CHAIR WITH 310 DELIVERY ENGLE 1200 PACKAGE WITH ENGLE 310 CHAIR, AND 1200 OR 2200 DELIVERY SYSTEM ENGLE 320 PACKAGE WITH ENGLE 300 CHAIR WITH 320 DELIVERY ENGLE DELIVERY CART ENGLE REAR DELIVERY ENGLE HYGIENE PACKAGE ENGLE SIDE DELIVERY ENGLE PANEL MOUNT DELIVERY ENGLE WALL MOUNTED DELIVERY E300 LED Ceiling Mounted Dental Light System E300 LED Post Mount Dental Light System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NRU	Chair, Dental, Without Operative Unit	Dental	Class 1	872.6250	2021-09-13
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2014-10-06
EAZ	Light, Operating, Dental	Dental	Class 1	872.4630	2020-03-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ENGLE DENTAL SYSTEMS, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020989. Last updated year: 2026. Please use registration number 3020989 when referencing this establishment in official correspondence.