Data / Medical devices / United States / Five Star Orthodontic Laboratory & Supply, Inc.
Five Star Orthodontic Laboratory & Supply, Inc.: FDA-registered device maker in Denton, TX, United States, 39 510(k) clearances
Five Star Orthodontic Laboratory & Supply, Inc. is registered with the FDA (registration 1000118628) in Denton, TX, United States. It lists 24 device types. The FDA files 39 510(k) clearances under its listings, the newest dated June 19, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000118628
- Address
- 2928 Metro Street Suite 102, Denton, TX, United States, 76207
- Owner or operator
- Five Star Orthodontic Laboratory & Supply, Inc. (10033551)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 5, 2013
- Registered through
- 2026
- Brand names listed
- 3-Way Anterior Sagittal w/ S Bow, 3-Way Schwarz W/Duo-T Springs, 3X3 Banded Ling Ret W/Blank Ba, 3X3 Bonded Lingual W/2 Pads, 3X3 Bonded Lingual W/6 Pads, 3X3 Braided Lingual Retainer, 3X3 Spring W/Ball Clasps, 4X4 Bonded Lingual Retainer 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 |
|---|---|---|---|---|---|---|
| June 19, 2019 | K182658 | Bioliner | NXC | Substantially Equivalent | Five Star Orthodontic Lab & Supply | accessdata.fda.gov |
| November 17, 2011 | K112118 | DREAMBOND | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| May 19, 2011 | K110335 | CERAMIC BRACKETS | NJM | Substantially Equivalent | Ortho Organizers, Inc. | accessdata.fda.gov |
| February 4, 2010 | K093059 | SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT | EBC | Substantially Equivalent | Classone Orthodontics, Inc. | accessdata.fda.gov |
| July 16, 2008 | K080445 | LION SE ONE STEP ORTHODONTIC ADHESIVE | DYH | Substantially Equivalent | Classone Orthodontics, Inc. | accessdata.fda.gov |
| September 7, 2007 | K071688 | RELIANCE S.E.P. | KLE | Substantially Equivalent | Reliance Orthodontic Products, Inc. | accessdata.fda.gov |
| October 15, 2004 | K041718 | KELES FACEMASK | DZB | Substantially Equivalent | Great Lakes Orthodontics, Ltd. | accessdata.fda.gov |
| August 1, 2002 | K021503 | UNINHIBITED | EBD | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| July 7, 2000 | K001494 | MODIFICATION TO PROMPT L-POP | KLE | Substantially Equivalent | Espe Dental AG | accessdata.fda.gov |
| June 9, 2000 | K000358 | MULTI ADJUSTABLE FACE MASK | DZB | Substantially Equivalent | Ortho Technology | accessdata.fda.gov |
| April 27, 2000 | K001048 | LIGHT BOND (QUICK CURE) | DYH | Substantially Equivalent | Reliance Orthodontic Products, Inc. | accessdata.fda.gov |
| February 24, 1998 | K980053 | GLENROE CHAIN | ECI | Substantially Equivalent | Glenroe Technologies | accessdata.fda.gov |
| December 1, 1997 | K973495 | GLENROE GLOW IN DARK ELASTOMERIC LIGATURES | ECI | Substantially Equivalent | Glenroe | accessdata.fda.gov |
| July 10, 1996 | K961754 | SAFETY RELEASE MODULE | DZB | Substantially Equivalent | G & H Wire Co. | accessdata.fda.gov |
| May 24, 1996 | K961417 | GC FUJI ORTHO | DYH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| March 8, 1995 | K950556 | FUJI ORTHO LC | DYH | Substantially Equivalent | GC America, Inc. | accessdata.fda.gov |
| January 27, 1995 | K945535 | GLENROE ORTHO-SIL | EGD | Substantially Equivalent | Glenroe Technologies | accessdata.fda.gov |
| January 3, 1995 | K945604 | ECLIPTOMER | KLE | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| September 13, 1993 | K923218 | NITANIUM PALATAL EXPANDER | EJF | Substantially Equivalent | Ortho Organizers, Inc. | accessdata.fda.gov |
| September 1, 1993 | K931980 | STAINLESS STEEL ORTHODONTIC PRODUCTS | DYO | Substantially Equivalent | Ortho Organizers, Inc. | accessdata.fda.gov |
| July 22, 1993 | K931462 | GLENROE CHAIN | ECI | Substantially Equivalent | Glenroe Technologies, Inc. | accessdata.fda.gov |
| July 8, 1993 | K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | EJF | Substantially Equivalent | Ortho Organizers, Inc. | accessdata.fda.gov |
| April 8, 1993 | K924139 | GLENROE ORTHO SEPS | ECI | Substantially Equivalent | Glenroe Technologies | accessdata.fda.gov |
| March 31, 1993 | K926238 | BISCO PORCELAIN ETCHING GEL | EIH | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| March 31, 1993 | K924805 | ORTHODONTIC ARCH WIRE | DZC | Substantially Equivalent | Ultimate Wireforms, Inc. | accessdata.fda.gov |
| March 31, 1993 | K923837 | DIMPLED MULTI MODULUS ARCH WIRE | DZC | Substantially Equivalent | Ultimate Wireforms, Inc. | accessdata.fda.gov |
| December 28, 1992 | K924151 | BISCO D/C RESINOMER | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| December 4, 1992 | K923838 | THE ULTIMATE RCS ARCH WIRE | DZC | Substantially Equivalent | Ultimate Wireforms, Inc. | accessdata.fda.gov |
| October 15, 1992 | K923839 | NITINOL GENTLE TOUCH COIL SPRING | DZC | Substantially Equivalent | Ultimate Wireforms, Inc. | accessdata.fda.gov |
| August 13, 1990 | K902390 | AURA CERAMIC DENTAL APPLIANCE | EJF | Substantially Equivalent | Progressive Technology, Inc. | accessdata.fda.gov |
| December 7, 1989 | K895522 | LIGHT BOND PASTE W/FLUORIDE | DYH | Substantially Equivalent | Reliance Orthodontic Products, Inc. | accessdata.fda.gov |
| December 7, 1989 | K895521 | RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE) | DYH | Substantially Equivalent | Reliance Orthodontic Products, Inc. | accessdata.fda.gov |
| October 17, 1989 | K894564 | RELIANCE LIGHT CURE RETAINER ACRYLIC | EBI | Substantially Equivalent | Reliance Orthodontic Products, Inc. | accessdata.fda.gov |
| August 12, 1988 | K882482 | TRIAD ORTHODONTIC GEL | EBI | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| June 13, 1988 | K880793 | LIGHT BOND | DYH | Substantially Equivalent | Reliance Orthodontic Products, Inc. | accessdata.fda.gov |
| April 18, 1988 | K880790 | PORCELAIN PRIMER | DYH | Substantially Equivalent | Reliance Orthodontic Products, Inc. | accessdata.fda.gov |
| March 31, 1988 | K880393 | TRANSBOND LIGHT CURED ORTHODONTIC ADHESIVE | DYH | Substantially Equivalent | Unitek Corp. | accessdata.fda.gov |
| March 10, 1988 | K875313 | PORCELAIN VENEER RESIN CEMENT W/DUAL CURE CATALYST | EBF | Substantially Equivalent | Bisco, Inc. | accessdata.fda.gov |
| February 26, 1988 | K875143 | RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE) | DYH | Substantially Equivalent | Reliance Orthodontic Products, Inc. | accessdata.fda.gov |
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Updated June 19, 2019. 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.