Manufacturer registered with FDA
Innovative Material And Devices, Inc.
Wuxi, China. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 36
- 510(k) clearances
- 0as applicant
- Markets registered in
- 526 registrations outside the US
- Establishments
- 1China
Registered in 5 markets
Where regulators' registries name Innovative Material And Devices, Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Innovative Material And Devices, Inc. | 12 device types | — | Below |
| Colombia | INVIMA | Manufacturer | INNOVATIVE MATERIAL AND DEVICES, INC. | 9 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | INNOVATIVE MATERIAL AND DEVICES INCInnovative Material And Devices, Inc. | 8 | 2011–2015 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | INNOVATIVE MATERIAL AND DEVICES, INC.INNOVATIVE MATERIAL AND DEVICES, INC · Innovative Material and Devices Inc. | 7 | 2011–2019 | Pure Global AI |
| Israel | AMAR | Manufacturer | Innovative Material and Devices IncInnovative Material and Devices, Inc. | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Innovative Material And Devices, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | 1st Molar Etched Interior, 2nd Molar Etched Interior | 2006 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Braided Wires, NiTi Super Elastic Wires, NiTi Super Elastic RCS Wires, NiTi Thermal Active Wires,Cu-Alloy Tri MEMAlloy Wires, NiTi Coated Wires, Stainless Steel Coated WiresNiTi 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 | 2009 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | ActMIM Roth+ Buccal Tubes, Pluto Plus Buccal Tubes, ProMIM X Buccal Tubes, FOMIC Buccal Tubes | 2009 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Hestia Intraoral Elastics (variety of shape, color, size and length), Hestia SeparatorsHestia 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) | 2009 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | NiTi Close Springs, NiTi Open Springs, MEMAlloy Inter-Step Open Springs, MEMAlloy Open Springs | 2007 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | ActMIM Roth/McBeTr/Roth+ Interactive Self-Ligating Metal Brackets, High Torque/Low Torque,ProMIM IX Roth/McBeAtua, Ophro, Mini Arch, Copolla, Smile, Omni Plus, ACE Plus, McBeTr/Roth/Edgewise, Standard/Mini Metal Twin BracketsFOMIC Advanced Light Wires Passive Self-Ligating Metal BracketsProMIM Roth/McBeTr Standard Passive Self-Ligating Metal Brackets,ProMIM X,Tr Standard Passive Self-Ligating Metal Brackets, High Torque/Low Torque | 2007 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | NiTi Spreaders, Stainless Steel Pluggers, Dental Post, Absorbent Paper Points, Pulp Canal Filling Material, Endodontic | 2009 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha | 2009 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | Stainless Steel Reamers, NiTi Reamers | 2009 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | NiTi Pluggers, Stainless Steel Pluggers | 2009 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | NiTi MM Files, NiTi MTaper Files, NiTi MSolo Files, Gates Enlargers, Pesso Enlargers Opener,Wayfinder, Barbed BroachesNiTi MPro Files, NiTi MPro Smart Files, NiTi MPro Blue Files, NiTi MPilot Files, NiTi ReRoot FilesNiTi TeraRossa Rotary Files, NiTi TeraRossa Hand Files, Stainless Steel TeraRossa Micro FilesRoot Fillers, NiTi H Files, NiTi K Files, Stainless Steel CPilot Files, Stainless Steel H Files,Stainless Steel K Files, Engine use and Hand Files | 2009 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Adams Pliers, Distal End Cutters, Flush Cutters, Distal End Cutters, Mini Ligature & Pin Cutters, Ligature & Pin CuttersBonding Tweezers, Mathieu Needle Holder, Schure Band Seater, Mershon Band Pusher, Ligature Director,Cap Removing Pliers, Vertical Slot Forming Pliers, Horizontal Slot Forming Pliers, Tear Drop Thermal Forming Pliers,Hole Punch Thermal Forming Pliers, Distal End Cutters, Articulating Paper Holding TweezersHook Crimple Pliers, Individual Torquing Pliers Set, Band Seater Stick, Stop "V" Bend Pliers, Long Forming Pliers,How Utility Pliers, Bonding Tweezers, Improved Tweezers, Buccal Tube Tweezers,Johnson Contouring Pliers, Arch Forming Pliers, Loop Forming Pliers, TweedMini Ligature Cutters, Micro Ligature & Pin Cutters, Hard Wires Cutters, Heavy Duty Cutters, Band Removing Pliers, WeingMosquito Mathieu Needle Holder, Elastic Separating Pliers, Pliers Hanging Rack, BoonePliers, Brackets Removing Pliers, Three Jaw Pliers, Aderer Pliers, Bird Beak Pliers, Jaraback Pliers, 2 morePliers, Omega Loop Forming Pliers, Adhesive Removing PliersPositioning Gauge, Aluminum Height Gauge, Step Forming Pliers, Ligature Forming Pliers, NiTi Cinch Back Pliers, | 2009 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INNOVATIVE MATERIAL & DEVICES, INC.FDA reg. 3006621310 | Wuxi Jiangsu, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9096082). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.