Manufacturer registered with FDA

Inosys, Inc.

New York, NY, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10084921Repacker / relabelerSpecification developer1 clearance in five years

Device types listed: 2
Brands and models: 22
510(k) clearances: 12026–2026
Markets registered in: 1United States
Establishments: 1United States

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Inosys, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	Abutment ScrewCemented Abutment (HEX)Cemented Abutment (NON-HEX)Closing ScrewCover ScrewHealing AbutmentINOSS AbutmentINOSS FixtureINOSS SystemPRIMUS Implant System 1 more Stock Abutment	2022
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	Abutment ScrewCemented Abutment (HEX)Cemented Abutment (NON-HEX)Closing ScrewCover ScrewHealing AbutmentINOSS AbutmentINOSS FixtureINOSS SystemPRIMUS Implant System 1 more Stock Abutment	2022

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 Inosys, Inc. as the applicant.

Decided	510(k)	Device	Device type
17 Jun 2026	K260006	INOSS System	DZE Root-Form Endosseous Implant

Also lists devices cleared under other names

Inosys, Inc. 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: Biotem Co., Ltd. (1).

Decided	510(k)	Device	Applicant	Device type
31 Jan 2018	K171297	AR_N Type Implant System	Biotem Co., Ltd.	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
INOSYS, INC.FDA reg. 3022316560	New York, NY, United States	Repacker / relabeler, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10084921). 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.