Registered with FDA

Streamline Dental Laboratory

New York, NY, United States. Lists 2 dental device types with FDA across 1 registered establishment.

FDA owner/operator10025166Repacker / relabeler
Device types listed
2
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1United States

Devices listed with FDA

What Streamline Dental Laboratory currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Impression MaterialELW · Class 2Impression materialsLister—2021
Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2Intraoral scannersLister
CAD/CAM RESTORATION
2018

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Also lists devices cleared under other names

Streamline Dental Laboratory lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: Zhengzhou Huaer Electro-optics Technology Co., Ltd. (1).

Decided510(k)DeviceApplicantDevice type
8 Oct 2020K201483Impression MaterialZhengzhou Huaer Electro-optics Technology Co., Ltd.ELW Impression Material

Registered establishments

EstablishmentLocationWhat it does
STREAMLINE DENTAL PRODUCTS INC.FDA reg. 3007028587New York, NY, United StatesRepacker / relabeler

Other names on FDA records

Streamline Dental Products Inc.

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10025166). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.