Manufacturer registered with FDA
GoldenDent
Roseville, MI, United States. Lists 30 dental device types with FDA across 1 registered establishment.
- Device types listed
- 30
- Brands and models
- 52
- 510(k) clearances
- 0as applicant
- Markets registered in
- 27 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name GoldenDent as the manufacturer or the registration holder of a device.
RegisteredHome: United StatesOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | GoldenDent | 30 device types | — | Below |
| South Korea | MFDS | Manufacturer | GoldenDent | 7 | 2019–2019 | 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 GoldenDent currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Lister | FlashMaxO-Star Curing LightO-Star Pro Curnig LightX-Star Curing Light | 2021 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | AP-APiezo Implant MotorPT-APT-BPT-B miniPT-E | 2022 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | Piezo Implant Motor | 2022 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Deep Margin Elevation Wedgephysics forcepsQuick Connect Anatomy BandQuick Connect Intro Kitseparator Wedge | 2013 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | dental mirror | 2016 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Lister | GoldenDent | 2020 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | Dental Electric Motor, MT2, MT3, Controller Foot, Handpience and Cord, Contra and Right Angle attachment | 2023 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | Dental Air Polishing Handpiece | 2026 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | Dental Electric Motor, MT2, MT3, Controller Foot, Handpience and Cord, Contra and Right Angle attachment | 2023 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Irriflex Endo Irrigation | 2023 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | Vibraject; Vibraject Clip Brackets, Vibraject Motor and Housing, Vibraject Control Knob | 2015 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | SeeMore | 2020 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | WagoTrix Wedge | 2018 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | GoldenDent Bur Kit | 2020 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | PT-S1, PT-S3 / SANDBLASTING POWDER | 2018 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Lister | WagotrixWagotrix Sectional Matrix System | 2020 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | GoldenDent | 2020 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | GoldenDent | 2020 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Lister | GoldenDent | 2020 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | Gutta Percha Obturation Device, Fi-P, Fi-G, Fi-E, Plugger | 2023 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | Golden-Taper | 2020 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Endo Motor | 2022 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | GoldenDent | 2020 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Lister | GoldenForce | 2020 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Lister | GMX 69, Distal Elevator, Buccal Elevator, Lingual Elevator, The Wedge, The Reflector, CowhornsSeparators | 2020 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Lister | GoldenDent | 2020 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Maker | Anatomical MatrixWagoTrix Matrix Into KitWagoTrix Sectional Matrix System; Class W; Class XWagoTrix Universal Matrix Ring | 2018 |
| AirbrushKOJ · Class 2 | — | Lister | AP-APT-APT-BPT-B miniPT-E | 2023 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | X-Ray | 2025 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | SpotterWam Key, MD Guide | 2014 |
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
GoldenDent 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. (7), Soft-Core Texas, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 28 Sep 2022 | K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 13 Jan 2022 | K203706 | Dental Electric Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 10 Dec 2021 | K203615 | Dental Scaler and Air Polisher | Guilin Woodpecker Medical Instrument Co., Ltd. | ELC Ultrasonic Scaler |
| 27 Sep 2021 | K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | MUH Digital Extraoral Source X-Ray System |
| 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 |
| 28 Nov 2000 | K002991 | ZAP DUAL CURING LIGHT | Soft-Core Texas, Inc. | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GoldenDentFDA reg. 3005972890 | Roseville, MI, United States | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9090600). 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.