Manufacturer registered with FDA
A. Titan Instruments, Inc.
Orchard Park, NY, United States. Lists 16 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 16
- Brands and models
- 15
- 510(k) clearances
- 12006–2006
- Markets registered in
- 649 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name A. Titan Instruments, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | A. Titan Instruments, Inc. | 1 clearances | 2006–2006 | Below |
| South Korea | MFDS | Manufacturer | A. TITAN Instruments, Inc.A.Titan Instruments, Inc. · A. TITAN INSTRUMENTS, INC. · +2 | 45 | 2000–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | A. TITAN INSTRUMENTS, INC | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | A.Titan Instruments | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | A. Titan Instruments | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | A. TITAN INSTRUMENTS, INC. | 1 | 2006–2006 | 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 A. Titan Instruments, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
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 A. Titan Instruments, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Jun 2006 | K060691 | EASY X-TRAC SYSTEM | EMG Surgical Tooth Extractor Forceps |
Some of these clearances are listed with FDA today by another company: Arnold Tuber Industries (1).
Also lists devices cleared under other names
A. Titan Instruments, 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: Aesculap Instruments Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 20 Aug 1980 | K801886 | BURR, DENTAL | Aesculap Instruments Corp. | EJL Dental Bur |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| A. TITAN INSTRUMENTS, INC.FDA reg. 2531684 | Orchard Park, NY, United States | Contract manufacturer, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9035364). 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.