Reliance Orthodontic Products, Inc.
Itasca, IL, US
RELIANCE ORTHODONTIC PRODUCTS, INC. appears in FDA device records in Itasca, IL. FDA records list 32 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 32 510(k) clearances for Reliance Orthodontic Products, Inc. between 1988 and 2021. The busiest year on record is 1988, with 10. The most recent is 2021, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 10 |
| 1989 | 6 |
| 1993 | 1 |
| 1994 | 1 |
| 2000 | 1 |
| 2003 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 2 |
| 2016 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210349 | TKO Composite Bite Turbo Gel | EBF | Substantially Equivalent | |
| K210945 | Ultra SEP | KLE | Substantially Equivalent | |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | DYH | Substantially Equivalent | |
| K161684 | Quantum LB | DYH | Substantially Equivalent | |
| K130237 | PONTIC PAINT | NXC | Substantially Equivalent | |
| K123348 | CLEAR ALIGNER ADHESIVE | DYH | Substantially Equivalent | |
| K111814 | PADLOCK | DYH | Substantially Equivalent | |
| K101951 | LIGHT CURE RETAINER | DYH | Substantially Equivalent | |
| K083051 | FLOWTAIN & FLOWTAIN LV | DYH | Substantially Equivalent | |
| K073243 | LED PRO SEAL | EBD | Substantially Equivalent | |
| K071688 | RELIANCE S.E.P. | KLE | Substantially Equivalent | |
| K071590 | THERMA-CURE | DYH | Substantially Equivalent | |
| K033551 | EVOLVE | DYH | Substantially Equivalent | |
| K001048 | LIGHT BOND (QUICK CURE) | DYH | Substantially Equivalent | |
| K934405 | PRECEDENT | EMA | Substantially Equivalent | |
| K925712 | RELIANCE SHORT STICK TIE | DYX | Substantially Equivalent | |
| K895523 | PHASE II ORTHODONTIC ADHESIVE | DYH | Substantially Equivalent | |
| K895522 | LIGHT BOND PASTE W/FLUORIDE | DYH | Substantially Equivalent | |
| K895521 | RELY-A-BOND W/FLUORIDE (NO MIX ADHESIVE) | DYH | Substantially Equivalent | |
| K894564 | RELIANCE LIGHT CURE RETAINER ACRYLIC | EBI | Substantially Equivalent | |
| K894565 | LIGHT BOND SEALANT WITH FLUORIDE | DYH | Substantially Equivalent | |
| K894566 | MAXIMUM CURE SEALANT WITH FLUORIDE | DYH | Substantially Equivalent | |
| K880793 | LIGHT BOND | DYH | Substantially Equivalent | |
| K880791 | MAXIMUM CURE SEALANT | DYH | Substantially Equivalent | |
| K880766 | RELIANCE METAL PRIMER | DYH | Substantially Equivalent | |
| K880792 | PLASTIC PRIMER | DYH | Substantially Equivalent | |
| K880790 | PORCELAIN PRIMER | DYH | Substantially Equivalent | |
| K875142 | PHASE II | DYH | Substantially Equivalent | |
| K875145 | MAR BOND | EBG | Substantially Equivalent | |
| K875144 | EXCEL FAST SET | DYH | Substantially Equivalent | |
| K875143 | RELY-A-BOND(NO MIX ORTHODONTIC ADHESIVE) | DYH | Substantially Equivalent | |
| K875141 | EXCEL REGULAR SET | DYH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1420089 | 1420089 | RELIANCE ORTHODONTIC PRODUCTS, INC. | 1540 WEST THORNDALE AVE., ITASCA, IL 60143 US | 2026 | and 16 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EIFAccessories, Retractor, Dental
- EBZActivator, Ultraviolet, For Polymerization
- DYHAdhesive, Bracket And Tooth Conditioner, Resin
- EJRAgent, Polishing, Abrasive, Oral Cavity
- KLEAgent, Tooth Bonding, Resin
- KOJAirbrush
- NXCAligner, Sequential
- KXRApplicator, Resin
- ECIBand, Elastic, Orthodontic
- EJFBracket, Metal, Orthodontic
- EJLBur, Dental
- EMACement, Dental
- ECNClamp, Wire, Orthodontic
- EBDCoating, Filling Material, Resin
- EBGCrown And Bridge, Temporary, Resin
- EHKCup, Prophylaxis
- ECPInstrument, Ligature Tucking, Orthodontic
- DZNInstruments, Dental Hand
- PFLIntraoral, Dental Foam Protector
- EAYLight, Fiber Optic, Dental
- DYXLock, Wire, And Ligature, Intraoral
- EBFMaterial, Tooth Shade, Resin
- EHLPoint, Abrasive
- EIHPowder, Porcelain
- EBIResin, Denture, Relining, Repairing, Rebasing
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- EGDWax, Dental, Intraoral
- DZCWire, Orthodontic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain