Manufacturer registered with FDA
The Anspach Effort Inc
Palm Beach Gardens, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 12158 registrations outside the US
- Establishments
- 1United States
Registered in 12 markets
Where regulators' registries name The Anspach Effort 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 | The Anspach Effort Inc | 2 device types | — | Below |
| Saudi Arabia | SFDA | Manufacturer | The Anspach Effort, Inc. | 52 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | The Anspach Effort, Inc.THE ANSPACH EFFORT INC. · THE ANSPACH EFFORT. INC. · +2 | 33 | 2000–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | The Anspach Effort Inc | 27 | 2010–2020 | Pure Global AI |
| Canada | Health Canada | Registration holder | THE ANSPACH EFFORT INC. | 24 | 1998–2009 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | THE ANSPACH EFFORT, INC. | 5 | 2005–2015 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | The Anspach Effort, Inc | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | THE ANSPACH EFFORT INC | 4 | 2017–2022 | Pure Global AI |
| China | NMPA | Registration holder | 安世佰动力股份有限公司The Anspach Effort, Inc.安世佰动力股份有限公司The Anspach Effort,Inc. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | The Anspach EffortThe Anspach Effort Inc. | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | THE ANSPACH EFFORT INC | 2 | 2015–2015 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | THE ANSPACH EFFORT, INC. | 1 | — | 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 The Anspach Effort 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 |
|---|---|---|---|---|
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Electric Pen DriveSynthes | 2025 |
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | Synthes | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
The Anspach Effort 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: Synthes (Usa) (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Apr 2009 | K082649 | SYNTHES 90 DEGREE SCREWDRIVER | Synthes (Usa) | DZI Powered Bone Drill |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| THE ANSPACH EFFORT, INC.FDA reg. 1045834 | Palm Bch Gdns, FL, United States | Complaint file establishment, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1045834). 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.