Manufacturer registered with FDA

ZEROS Co., Ltd.

Gimhae-si, South Korea. Lists 3 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10094653Manufacturer2 clearances in five years

Device types listed: 3
Brands and models: 42
510(k) clearances: 22024–2026
Markets registered in: 22 registrations outside the US
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name ZEROS Co., Ltd. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: South KoreaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	ZEROS Co., Ltd.	2 clearances	2024–2026	Below
European Union	EUDAMED	Manufacturer	ZEROS Co., Ltd.	2	—	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What ZEROS 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
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	IOS AbutmentSTERI-OSS Implant SystemZEROS Dental Implant System	2025
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	STERI-OSS Implant SystemZEROS Dental Implant System	2025
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	Abutment Lab AnalogBall DriverBall Lab AnalogCrest BurrDrill ExtensionDrill StopperEsthetic DriverEsthetic Lab AnalogEsthetic Pick-up Impression CopingFixture Lab Analog 27 more Hand DriverHandpiece ConnectorHard Bone DrillHard-Shaper DrillImpression Coping Guide PinIOS Hybrid Torque Wrench TipIOS Optimax ToolLindemann DrillMachine DriverParallel PinPick-up Impression CopingPoint DrillPoint Marking DrillRachet ConnectorRachet WrenchRatchet Hex DriverSoft-Shaper DrillSpread DrillStep DrillStopper DrillTissue PunchTorque AdapterTorque ConnectorTorque WrenchTransfer Impression CopingTwist DrillWing Guide Drill	2025

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 ZEROS Co., Ltd. as the applicant.

Decided	510(k)	Device	Device type
19 Aug 2026	K260463	ZEROS Dental Implant System	DZE Root-Form Endosseous Implant
25 Mar 2024	K232268	STERI-OSS Implant System	DZE Root-Form Endosseous Implant

Also lists devices cleared under other names

ZEROS Co., Ltd. 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: Seum Medi Co., Ltd. (1).

Decided	510(k)	Device	Applicant	Device type
28 Jul 2025	K241183	ISO Abutment	Seum Medi Co., Ltd.	NHA Endosseous Dental Implant Abutment

Registered establishments

Establishment	Location	What it does
ZEROS CO., LTD.FDA reg. 3032439351	Gimhae-si Gyeongnam, South Korea	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10094653). 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.