Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004201548

FEI Number

3004201548

Entity Name

MIDWEST DENTAL

City/State/Country

Wichita Falls, TX, US

Establishment Address

2700 Commerce St, Wichita Falls, TX 76301, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Midwest Dental (Owner Number: 10089806)

Owner / Operator Contact Address

2700 Commerce St, Wichita Falls, TX 76301, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221875

PMA Number

N/A

All Registered Proprietary Names

Advance NiTi Super-Elastic Reverse Curve Archwire Advance Copper NiTi Archwire Advance Stainless Steel Archwire Advance Pure Ice Advance Pure Ice S Advance SonicTouch Rechargeable Toothbrush Advance Screws Advance Precision Series Springs Advance Pure ICE Bonding Tubes Advance Precision Series Bonding Tubes Advance Precision Premium Bonding Tubes Advance Elastic Chain, 5ft Advance Elastic Separators Advance Elastic Chain, 15ft Advance Ortho Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2024-06-17
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2026-01-13
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2024-06-17
IWX	Barrier, Control Panel, X-Ray, Movable	Radiology	Class 1	892.6500	2026-01-13
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2026-01-13
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2024-07-23
KHR	Absorber, Saliva, Paper	Dental	Class 1	872.6050	2026-01-13
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2024-06-17
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2024-06-17
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2026-01-13
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2024-06-17
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2024-06-17
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2026-01-13
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2026-01-13
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2024-06-17
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2026-01-13
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2026-01-13

Official Correspondent

James Cluley

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Midwest Dental

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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004201548. Last updated year: 2026. Please use registration number 3004201548 when referencing this establishment in official correspondence.