Manufacturer registered with FDA

Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.

Suzhou City, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10095056Manufacturer1 clearance in five years

Device types listed: 1
Brands and models: 1
510(k) clearances: 12025–2025
Markets registered in: 1United States
Establishments: 1China

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Intraoral Animal Source BarrierNPL · Class 2	Bone grafts & membranes	Maker	Neocirrus Augmented Gingival Matrix	2026

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

510(k) clearances

Clearances on which FDA names Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
5 Dec 2025	K250512	Augmented Gingival Matrix	NPL Intraoral Animal Source Barrier

Registered establishments

Establishment	Location	What it does
NEO MODULUS (SUZHOU) MEDICAL SCI-TECH CO., LTD.FDA reg. 3043657402	Suzhou City Jiangsu, China	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10095056). 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.