Manufacturer registered with FDA
Hager Worldwide, Inc.
Hickory, NC, United States. Lists 29 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 29
- Brands and models
- 70
- 510(k) clearances
- 22005–2005
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Devices listed with FDA
What Hager Worldwide, 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Bio Vacuum TipComfi-TipsMirasuctoMirror SuctionMirror Suction Double SidedPelotteSevdopterSurgical TipSwe-FlexVacuum Tip | 2022 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Del-Ject Carrier, Tips, Spring, Piston | 2023 |
| Dental Fiber Optic LightEAY · Class 1 | Dental operating lights | Lister | — | 2023 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Almore SurfactantMiracast | 2022 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | Almore Markley Wire | 2022 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Access TipDura-SyringeDuration TipUni-SryingeUni-Tip | 2023 |
| Articulation PaperEFH · Class 1 | — | Maker | Madam ButterflyMylar FoilOcclu-PlusShimstockTrollFoil | 2023 |
| Roll CottonEFN · Class 1 | — | Lister | Quick Clip | 2024 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | — | 2022 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Almore Bite Registration Wax and TabsAlmore Inlay WaxAlmore Margin WaxAlmore Powdered Wax | 2022 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | SalibagSoft Bitewing Flap | 2024 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | — | 2022 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | Hager Prophy AnglesHager Prophy BrushesRotoprox | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | AlgilockMiracold Plus SprayMiratray Adhesvie SprayMiratray Implant Advanced | 2022 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Bull Frog HVEs, Saliva Ejectors, and Accessories | 2023 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Lister | Bite-BlockLip-ExMiraholdSpandexSpandex AdvancedUni-Wedge | 2022 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | Almore Electra WaxerAlmore Mini WaxerAlmore Soft Lining TrimmerHager Wax Carving Set | 2022 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Lister | — | 2023 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Lister | Crown Click DeLuxeHager Wyman Crown HolderMetaLiftRichwil | 2022 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Lister | Plast Frame | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | — | 2023 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Lister | Almore Aluminum OxideComp-Blitz | 2023 |
| Operative Matrix Contouring InstrumentEKF · Class 1 | Dental hand instruments | Maker | Almore Microfil Composite InstrumentsMadam ButterflyMylarOcclu-SpotShimstock | 2022 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Lister | MirafitMirapost | 2024 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Reso Pac | 2023 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | White SafeDispenseZahn PickZahn Pick Soft + | 2022 |
| Tongue ScraperLCN · Class 1 | — | Lister | Tong-ClinTS1 | 2024 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | — | 2023 |
| Plaque Disclosing AgentQJC · Class 1 | — | Lister | Quick-Detect | 2025 |
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 Hager Worldwide, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Jul 2005 | K043322 | MIRAMATIC SAFE SYRINGE SYSTEM | EJI Cartridge Syringe |
| 27 May 2005 | K050658 | RESO-PAC PERIODONTAL DRESSING | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: Hager & Werken (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HAGER WORLDWIDE, INC.FDA reg. 1044031 | Hickory, NC, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 3022877). 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.