Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1044031

FEI Number

1044031

Entity Name

HAGER WORLDWIDE, INC.

City/State/Country

Hickory, NC, US

Establishment Address

441 19th St SE, Hickory, NC 28602, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Repack or Relabel Medical Device

Owner / Operator

HAGER WORLDWIDE, INC. (Owner Number: 3022877)

Owner / Operator Contact Address

441 19th Street SE, --, Hickory, NC 28602, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Almore Catalina Waerbath Quick-Detect Outback's Zoom Magnifiers Comfort Fit Magnifiers Felines Jewels Dream Shields Avions Reso Pac Duration Tip Uni-Tip Dura-Syringe Uni-Sryinge Access Tip Zahn Pick White SafeDispense Zahn Pick Soft + Comfi-Tips Surgical Tip Mirror Suction Double Sided Mirror Suction Mirasucto Bio Vacuum Tip Pelotte Vacuum Tip Sevdopter Swe-Flex Almore Anaerobic Jar Econo Tips Mirabrush Quick Tips Super Quick Tips Plast Frame Almore Microfil Composite Instruments Occlu-Spot Mylar Madam Butterfly Shimstock BioGuard Evacuation System Cleaner Dental Tweezers Mirapost Mirafit Quick Clip Almore Markley Wire Del-Ject Carrier, Tips, Spring, Piston Almore Bite Registration Wax and Tabs Almore Inlay Wax Almore Powdered Wax Almore Margin Wax Almore Soft Lining Trimmer Hager Wax Carving Set Almore Electra Waxer Almore Mini Waxer TS1 Tong-Clin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2022-07-05
EJL	Bur, Dental	Dental	Class 1	872.3240	2023-11-29
JTQ	Bath, Incubators/Water, All	Microbiology	Class 1	866.2540	2022-07-05
EAY	Light, Fiber Optic, Dental	Dental	Class 1	872.4620	2023-03-30
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2023-08-25
QJC	Plaque Disclosing Agent	Dental	Class 1	872.6855	2025-01-22
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2023-03-30
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2022-09-07
EMA	Cement, Dental	Dental	Class 2	872.3275	2023-08-04
ECB	Unit, Syringe, Air And/Or Water	Dental	Class 1	872.4565	2023-02-24
JES	Floss, Dental	Dental	Class 1	872.6390	2022-07-05
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2022-07-05
JTM	Anaerobic Box Glove	Microbiology	Class 1	866.2120	2022-07-05
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2023-03-30
EJE	Frame, Rubber Dam	Dental	Class 1	872.6300	2024-09-20
EKF	Instrument, Contouring, Matrix, Operative	Dental	Class 1	872.4565	2022-07-05
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-08-09
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2023-08-25
ELR	Post, Root Canal	Dental	Class 1	872.3810	2024-09-20
EFN	Cotton, Roll	Dental	Class 1	872.6050	2024-05-31
EBL	Pin, Retentive And Splinting, And Accessory Instruments	Dental	Class 1	872.3740	2022-07-05
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2023-03-30
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2022-07-05
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2022-07-05
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2022-12-16
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2024-02-16

Official Correspondent

Patrick Rouillard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HAGER WORLDWIDE, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831824	Silverman'S	DENTAL ELECTRONIC/S.B.R TRADING BU HAND	1983-08-11
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09

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3012187973	JERSEY DENTAL SUPPLIES	Lakewood, NJ, US
3002808149	SHOFU INC.	FUKUINE, HIGASHIYAMA-KU Kyoto, JP
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1044031. Last updated year: 2026. Please use registration number 1044031 when referencing this establishment in official correspondence.