Data / Medical devices / United States / Hager Worldwide, Inc.
Hager Worldwide, Inc.: FDA-registered device maker in Hickory, NC, United States, 1 510(k) clearance
Hager Worldwide, Inc. is registered with the FDA (registration 1044031) in Hickory, NC, United States. It lists 35 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 27, 2005. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1044031
- Address
- 441 19th St SE, Hickory, NC, United States, 28602
- Owner or operator
- HAGER WORLDWIDE, INC. (3022877)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 5, 2022
- Registered through
- 2026
- Brand names listed
- Access Tip, Algilock, Almore Aluminum Oxide, Almore Anaerobic Jar, Almore Bite Registration Wax and Tabs, Almore Electra Waxer, Almore Inlay Wax, Almore Margin Wax and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Anaerobic Box Glove | JTM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Carver, Wax, Dental | EIK | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cotton, Roll | EFN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Disk, Abrasive | EHJ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Floss, Dental | JES | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Frame, Rubber Dam | EJE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Holder, Film, X-Ray | EGZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Instrument, Contouring, Matrix, Operative | EKF | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Light, Fiber Optic, Dental | EAY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Paper, Articulation | EFH | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Plaque Disclosing Agent | QJC | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Remover, Crown | EIS | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Unit, Operative Dental, Accessories | NRD | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Unit, Syringe, Air And/Or Water | ECB | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 27, 2005 | K050658 | RESO-PAC PERIODONTAL DRESSING | EMA | Substantially Equivalent | Hager Worldwide, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Tray, Impression, Preformed
- All makers of Pin, Retentive And Splinting, And Accessory Instruments
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Evacuator, Oral Cavity
- All makers of Instrument, Contouring, Matrix, Operative
Updated May 27, 2005. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.