Manufacturer registered with FDA
Nordent MFG., Inc.
Elk Grove Village, IL, United States. Lists 53 dental device types with FDA across 1 registered establishment.
- Device types listed
- 53
- Brands and models
- 60
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Nordent MFG., 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
Also lists devices cleared under other names
Nordent MFG., 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: Guilin Woodpecker Medical Instrument Co., Ltd. (8), Ttbio Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Nov 2022 | K222569 | Ai Ray Dental X-Ray Device | Guilin Woodpecker Medical Instrument Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 21 Nov 2022 | K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 28 Sep 2022 | K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 2 Feb 2022 | K210832 | EVOCLEAN CLEANsert Ultrasonic Insert | Ttbio Corp. | ELC Ultrasonic Scaler |
| 13 Jan 2022 | K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 10 May 2021 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EKX Ac-Powered Direct Drive Handpiece |
| 18 Nov 2011 | K111290 | PIEZO BONE SURGERY | Guilin Woodpecker Medical Instrument Co., Ltd. | DZI Powered Bone Drill |
| 19 Mar 2008 | K080025 | LED.L, LED.M, LED.G, LED.B | Guilin Woodpecker Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 21 Aug 2006 | K053555 | ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L | Guilin Woodpecker Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| NORDENT MFG., INC.FDA reg. 1419489 | ELK GROVE VILLAGE, IL, United States | Contract manufacturer, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1419489). 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.