Manufacturer registered with FDA

Scitek Global Co.,Ltd

Jinan, China. Lists 1 dental device type with FDA across 1 registered establishment.

FDA owner/operator10094524Foreign exporterManufacturer
Device types listed
1
Brands and models
1
510(k) clearances
0as applicant
Markets registered in
1United States
Establishments
1China

Devices listed with FDA

What Scitek Global Co.,Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Mouth MirrorEAX · Class 1Dental hand instrumentsMaker
Mouth Mirror
2025

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

Registered establishments

EstablishmentLocationWhat it does
SCITEK GLOBAL CO.,LTDFDA reg. 3043088937Jinan Shandong, ChinaForeign exporter, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10094524). 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.