Data / Medical devices / United States / International Orthodontic Services, PC
International Orthodontic Services, PC: FDA-registered device maker in Stafford, TX, United States, 6 510(k) clearances
International Orthodontic Services, PC is registered with the FDA (registration 3008524225) in Stafford, TX, United States. It lists 27 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 18, 2007. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008524225
- Address
- 12811 Capricorn Dr, Stafford, TX, United States, 77477
- Owner or operator
- International Orthodontics Services. PC (10032941)
- Roles
- Repackager or relabeler
- First device listed
- June 25, 2010
- Registered through
- 2026
- Brand names listed
- 13-400-100 to 125 Limber, Copper NiTi Natural Form - 27, 13-401-100 to 125 Limber, Copper NiTi Broad Form - 27, 13-402-100 to 125 Limber, Copper NiTi Natural Form - 35, 13-403-100 to 125 Limber, Copper NiTi Broad Form - 35, Abrasive Strip single / double fine and medium, Baby Mosquito and Regular, Ball Clasps sizes 028 to 036, Band-Guard and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 18, 2007 | K073045 | SAPPHIRE CERAMIC BRACKET | NJM | Substantially Equivalent | Ortho Technology, Inc. | accessdata.fda.gov |
| July 26, 2007 | K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | OAT | Substantially Equivalent | Biomaterials Korea, Inc. | accessdata.fda.gov |
| April 4, 2002 | K020946 | ADPER PROMPT | KLE | Substantially Equivalent | 3M Espe AG Dental Products | accessdata.fda.gov |
| October 24, 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | DYH | Substantially Equivalent | Prime Dental Manufacturing, Inc. | accessdata.fda.gov |
| April 6, 1998 | K980151 | RELEASABLE FORCE MODULE | DZB | Substantially Equivalent | Ortho Kinetics Corp. | accessdata.fda.gov |
| April 29, 1992 | K920483 | 10% PHOSPHORIC ACID ETCHING GEL | EBF | Substantially Equivalent | Pulpdent Corp. | accessdata.fda.gov |
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Updated December 18, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.