Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006621310

FEI Number

3006621310

Entity Name

INNOVATIVE MATERIAL & DEVICES, INC.

City/State/Country

Wuxi Jiangsu, CN

Establishment Address

Building 2, No. 345 Yanxin Rd.,, Huishan District, Wuxi Jiangsu 214174, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

INNOVATIVE MATERIAL & DEVICES, INC. (Owner Number: 9096082)

Owner / Operator Contact Address

Building 2, No. 345 Yanxin Rd.,, Huishan District,, Wuxi, CN-JS 214174, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Braided Wires, NiTi Super Elastic Wires, NiTi Super Elastic RCS Wires, NiTi Thermal Active Wires, NiTi Tri MEMAlloy Wires, MEMAlloy Wires, Bio MEMAlloy Wires, Beta-Ti Wires, Cu-Alloy NiTi Wires, Stainless Steel Wires, Stainless Steel Straight Wires, Stainless Steel Australian Wires, Stainless Steel Cu-Alloy Tri MEMAlloy Wires, NiTi Coated Wires, Stainless Steel Coated Wires 1st Molar Etched Interior, 2nd Molar Etched Interior NiTi Close Springs, NiTi Open Springs, MEMAlloy Inter-Step Open Springs, MEMAlloy Open Springs Gutta Percha Hestia Intraoral Elastics (variety of shape, color, size and length), Hestia Separators Hestia Ligature Ties (variety of shape, color, size and length), Hestia Power Chain (variety shape, color, size and leng (variety of shape, color, size and length), Q-Peak Separators (variety of shape, color, size and length) NiTi MM Files, NiTi MTaper Files, NiTi MSolo Files, Gates Enlargers, Pesso Enlargers Opener,Wayfinder, Barbed Broaches NiTi MPro Files, NiTi MPro Smart Files, NiTi MPro Blue Files, NiTi MPilot Files, NiTi ReRoot Files Stainless Steel K Files, Engine use and Hand Files Root Fillers, NiTi H Files, NiTi K Files, Stainless Steel CPilot Files, Stainless Steel H Files, Stainless Steel Reamers, NiTi Reamers Mosquito Mathieu Needle Holder, Elastic Separating Pliers, Pliers Hanging Rack, Boone Pliers, Brackets Removing Pliers, Three Jaw Pliers, Aderer Pliers, Bird Beak Pliers, Jaraback Pliers, Hole Punch Thermal Forming Pliers, Distal End Cutters, Articulating Paper Holding Tweezers How Utility Pliers, Bonding Tweezers, Improved Tweezers, Buccal Tube Tweezers, Hook Crimple Pliers, Individual Torquing Pliers Set, Band Seater Stick, Stop "V" Bend Pliers, Long Forming Pliers, Adams Pliers, Distal End Cutters, Flush Cutters, Distal End Cutters, Mini Ligature & Pin Cutters, Ligature & Pin Cutters Mini Ligature Cutters, Micro Ligature & Pin Cutters, Hard Wires Cutters, Heavy Duty Cutters, Band Removing Pliers, Weing Johnson Contouring Pliers, Arch Forming Pliers, Loop Forming Pliers, Tweed Cap Removing Pliers, Vertical Slot Forming Pliers, Horizontal Slot Forming Pliers, Tear Drop Thermal Forming Pliers, Pliers, Omega Loop Forming Pliers, Adhesive Removing Pliers Positioning Gauge, Aluminum Height Gauge, Step Forming Pliers, Ligature Forming Pliers, NiTi Cinch Back Pliers, Bonding Tweezers, Mathieu Needle Holder, Schure Band Seater, Mershon Band Pusher, Ligature Director, NiTi Spreaders, Stainless Steel Pluggers, Dental Post, Absorbent Paper Points, Pulp Canal Filling Material, Endodontic Tr Standard Passive Self-Ligating Metal Brackets, High Torque/Low Torque Atua, Ophro, Mini Arch, Copolla, Smile, Omni Plus, ACE Plus, McBeTr/Roth/Edgewise, Standard/Mini Metal Twin Brackets FOMIC Advanced Light Wires Passive Self-Ligating Metal Brackets ActMIM Roth/McBeTr/Roth+ Interactive Self-Ligating Metal Brackets, High Torque/Low Torque,ProMIM IX Roth/McBe ProMIM Roth/McBeTr Standard Passive Self-Ligating Metal Brackets,ProMIM X, ActMIM Roth+ Buccal Tubes, Pluto Plus Buccal Tubes, ProMIM X Buccal Tubes, FOMIC Buccal Tubes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2009-12-11
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	2006-12-28
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2007-01-11
EKM	Gutta-Percha	Dental	Class 1	872.3850	2009-12-11
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2009-12-11
EKS	File, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2009-12-11
EKP	Reamer, Pulp Canal, Endodontic	Dental	Class 1	872.4565	2009-12-11
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2009-12-11
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2009-12-11
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2007-01-11
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2009-12-11

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

INNOVATIVE MATERIAL & DEVICES, 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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K864976	Endo Technic Corp.	SOLUSET CALCIUM DEMINERALIZING SOLUTION	1987-02-27
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006621310. Last updated year: 2026. Please use registration number 3006621310 when referencing this establishment in official correspondence.