Registered with FDA
International Orthodontics Services. PC
Stafford, TX, United States. Lists 27 dental device types with FDA across 1 registered establishment.
- Device types listed
- 27
- Brands and models
- 66
- 510(k) clearances
- 0as applicant
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1United States
Registered in 3 markets
Where regulators' registries name International Orthodontics Services. PC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | International Orthodontics Services. PC | 27 device types | — | Below |
| Taiwan | TFDA | Manufacturer | INTERNATIONAL ORTHODONTIC SERVICES, PC | 4 | 2021–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | International Orthodontic Services, PC | 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 International Orthodontics Services. PC currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Bracket and Tooth Conditioner AdhesiveDYH · Class 2 | — | Lister | Band-Guard | 2016 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Lister | Expand-StickInfinity Expander 7mmInfinity Expander 9mmInfinity Mini ExpanderIOS Standard Palatal Expander | 2010 |
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Lister | Lingual Retainer 3-3Linguall Rerainer Gold | 2021 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Lister | Facebow Universal/ Short/ Medium/ Long | 2021 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | ExceloyIOS SSKoby Ligature wire Long / Short sizes 010 /012 /014Ligature Wire SS Long size 008 to 014Ligature wire SS Short regular / White / Gold size 012R-NiTispooled ligature wire sizes 008 to 014Ultimate NiTiUniversal Solder / EZ Solder13-400-100 to 125 Limber, Copper NiTi Natural Form - 27 3 more13-401-100 to 125 Limber, Copper NiTi Broad Form - 2713-402-100 to 125 Limber, Copper NiTi Natural Form - 3513-403-100 to 125 Limber, Copper NiTi Broad Form - 35 | 2010 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | Double Buccal TubesSingle Buccal TubesTriple Buccal Tubes | 2010 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | Photographic Mirror | 2021 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Lister | Blue EtchTopical Gel | 2024 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | IOS Ligature TiesMini Ligature O - Ties 15-112-100 to 134Ultimate Power Chain | 2010 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | IOS True Band | 2010 |
| Orthodontic Wire ClampECN · Class 1 | — | Lister | Bondable Button; Round, rectangular, Flat, Curved, Gold , ceramicEruption Appliance; Gold ChainSuper Lock; Buttons; Coil Eyelet; Crimpable Stop; Crimpable hook; X-Tube; Tongue Spikes; Bite wings | 2021 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Lister | DeimpactorUltimate Closed CoilUltimate Open CoilUprighting SpringWarren Spring | 2010 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Lister | IOS Band Pusher | 2010 |
| Intraoral Dental WaxEGD · Class 1 | — | Lister | Dental Wax | 2015 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Lister | Diamond Disc 3/4 and 7/8 | 2021 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Lister | Abrasive Strip single / double fine and medium | 2021 |
| Preformed ClaspEHP · Class 1 | — | Lister | Ball Clasps sizes 028 to 036Preformed Adam Clasp sizes 5 to 12 mm / Kits | 2021 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Lister | Liquid Dam | 2021 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | Cheeck RetractorNola Dry field | 2021 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | MajesticMaxRazorRoyal | 2010 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | Baby Mosquito and RegularCarbide Finishing BurLife Saver burWhite Stone | 2021 |
| Dental CementEMA · Class 2 | Dental cements | Lister | Durabond | 2016 |
| Matrix RetainerJEP · Class 1 | Dental hand instruments | Lister | Lingual 3 and 3Lingual 3-3 | 2010 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Lister | Brilliant Pliers | 2010 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | Durabond | 2016 |
| Orthodontic Ceramic BracketNJM · Class 2 | Orthodontic brackets | Lister | PhantomPhantom LPPhantom Luxe | 2010 |
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Lister | Infinity Implant System | 2010 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
International Orthodontics Services. PC lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Ortho Technology, Inc. (1), Biomaterials Korea, Inc. (1), 3M Espe AG Dental Products (1), Prime Dental Manufacturing, Inc. (1), Ortho Kinetics Corp. (1), Pulpdent Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Dec 2007 | K073045 | SAPPHIRE CERAMIC BRACKET | Ortho Technology, Inc. | NJM Orthodontic Ceramic Bracket |
| 26 Jul 2007 | K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | Biomaterials Korea, Inc. | OAT Orthodontic Endosseous Implant |
| 4 Apr 2002 | K020946 | ADPER PROMPT | 3M Espe AG Dental Products | KLE Resin Tooth Bonding Agent |
| 24 Oct 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | Prime Dental Manufacturing, Inc. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 6 Apr 1998 | K980151 | RELEASABLE FORCE MODULE | Ortho Kinetics Corp. | DZB Orthodontic Extraoral Headgear |
| 29 Apr 1992 | K920483 | 10% PHOSPHORIC ACID ETCHING GEL | Pulpdent Corporation | EBF Resin Tooth Shade Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| INTERNATIONAL ORTHODONTIC SERVICES, PCFDA reg. 3008524225 | Stafford, TX, United States | Repacker / relabeler |
Other names on FDA records
International Orthodontic Services, PC
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10032941). 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.