INTERNATIONAL ORTHODONTIC SERVICES, PC

FDA Device Registration & Listing · Stafford, TX, US · Registration 3008524225

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3008524225
FEI Number
3008524225
Entity Name
INTERNATIONAL ORTHODONTIC SERVICES, PC
City/State/Country
Stafford, TX, US
Establishment Address
12811 Capricorn Dr, Stafford, TX 77477, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
International Orthodontics Services. PC (Owner Number: 10032941)
Owner / Operator Contact Address
12811 Capricorn Dr, Stafford, TX 77477, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

IOS SS Exceloy Ultimate NiTi R-NiTi 13-400-100 to 125 Limber, Copper NiTi Natural Form - 27 spooled ligature wire sizes 008 to 014 Koby Ligature wire Long / Short sizes 010 /012 /014 13-401-100 to 125 Limber, Copper NiTi Broad Form - 27 Ligature Wire SS Long size 008 to 014 13-403-100 to 125 Limber, Copper NiTi Broad Form - 35 Ligature wire SS Short regular / White / Gold size 012 Universal Solder / EZ Solder 13-402-100 to 125 Limber, Copper NiTi Natural Form - 35 Liquid Dam IOS Band Pusher Abrasive Strip single / double fine and medium Blue Etch Topical Gel Infinity Implant System Dental Wax IOS Standard Palatal Expander Expand-Stick Infinity Expander 7mm Infinity Expander 9mm Infinity Mini Expander Band-Guard Durabond Brilliant Pliers Baby Mosquito and Regular Carbide Finishing Bur Life Saver bur White Stone Triple Buccal Tubes Double Buccal Tubes Single Buccal Tubes Lingual 3 and 3 Lingual 3-3 Ultimate Power Chain IOS Ligature Ties Mini Ligature O - Ties 15-112-100 to 134 Facebow Universal/ Short/ Medium/ Long Warren Spring Deimpactor Ultimate Open Coil Ultimate Closed Coil Uprighting Spring Eruption Appliance; Gold Chain Super Lock; Buttons; Coil Eyelet; Crimpable Stop; Crimpable hook; X-Tube; Tongue Spikes; Bite wings Bondable Button; Round, rectangular, Flat, Curved, Gold , ceramic Preformed Adam Clasp sizes 5 to 12 mm / Kits Ball Clasps sizes 028 to 036 Razor Max Royal Majestic Linguall Rerainer Gold Lingual Retainer 3-3 Diamond Disc 3/4 and 7/8

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DZC Wire, Orthodontic Dental Class 1 872.5410 2010-06-25
EIE Dam, Rubber Dental Class 1 872.6300 2021-08-09
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 2010-06-25
EHM Strip, Polishing Agent Dental Class 1 872.6010 2021-08-09
EBF Material, Tooth Shade, Resin Dental Class 2 872.3690 2024-12-04
OAT Implant, Endosseous, Orthodontic Dental Class 2 872.3640 2010-06-25
EGD Wax, Dental, Intraoral Dental Class 1 872.6890 2015-03-25
DYJ Retainer, Screw Expansion, Orthodontic Dental Class 1 872.5410 2010-06-25
DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental Class 2 872.3750 2016-12-20
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2016-12-21
EMA Cement, Dental Dental Class 2 872.3275 2016-12-21
JEX Plier, Orthodontic Dental Class 1 872.4565 2010-06-25
EJL Bur, Dental Dental Class 1 872.3240 2021-08-09
DZD Tube, Orthodontic Dental Class 1 872.5410 2010-06-25
JEP Retainer, Matrix Dental Class 1 872.4565 2010-06-25
ECI Band, Elastic, Orthodontic Dental Class 1 872.5410 2010-06-25
DZB Headgear, Extraoral, Orthodontic Dental Class 2 872.5500 2021-07-12
ECO Spring, Orthodontic Dental Class 1 872.5410 2010-06-25
ECN Clamp, Wire, Orthodontic Dental Class 1 872.5410 2021-07-12
EHP Clasp, Preformed Dental Class 1 872.3285 2021-07-12
EJF Bracket, Metal, Orthodontic Dental Class 1 872.5410 2010-06-25
DYT Maintainer, Space Preformed, Orthodontic Dental Class 1 872.5525 2021-08-09
EHJ Disk, Abrasive Dental Class 1 872.6010 2021-08-09

Official Correspondent

Wael Kanaan

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

International Orthodontics Services. PC
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
K040797 Britesmile, Inc. BRITESMILE MASKING CREAM 2004-04-02
K952662 Jeneric/Pentron, Inc. COMP=FLOW 1995-08-28
K171147 Bisco, Inc. REVEAL Bulk 2017-08-04
K770922 Espe GmbH (Us) DENTAL RESTORATIVE IN CAPSULES 1977-06-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0028-2020 Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany 2
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
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 307850***DISTRIBUTED 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 11-102-04***Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USA***MediMark Europe BP2332 F-38033 Grenoble Cedex 2. France***LOT 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008524225. Last updated year: 2026. Please use registration number 3008524225 when referencing this establishment in official correspondence.
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