Regulatory Compliance

International Regulatory Compliance Information

Listed below are regulatory compliance information that is frequently requested by customers. If you need any documents listed below legalized or apostilled, please send your request to the following: regulatory@americanortho.com

Quality Management System

ISO 13485 Quality System Certification
ISO 13485:2003 Certificate (129K)
CMDCAS ISO 13485 Quality System Certification (107K)

US FDA Good Manufacturing Practice (GMP)
We are fully compliant with 21 CFR 820, US FDA Quality Systems Regulations.

Notified Body/ Registrar/ Certification Body

American Orthodontics maintains ISO 13485:2003 Certification and is audited every year by:

Underwriter's Laboratory (UL) LLC
Northbrook, IL
http://www.ul.com/global/eng/pages/

Product Certifications and Approvals

Australia - Devices listed in ARTG
http://www.tga.gov.au/industry/artg.htm

Canada - Medical Device Licenses
http://www.hc-sc.gc.ca/dhp-mps/md-im/licen/mdlic-end.php

Europe - CE Marketing Certificates
CE Certificate (422K)

Declaration of Conformity Certificates

CERAMIC BRACKETS — EU/CE Class IIa

  • 201603-01 (65K) – Virage, 20/40, Radiance, Radiance Plus, Empower Clear

COMPOSITE BRACKETS — EU/CE Class IIa

  • 201603-02 (63K) – Classic Cosmetic Brackets - Sierra Gold, Sierra, Cosmetic Brackets - Sierra Classic, Silkon

SS BRACKETS — EU/CE Class IIa

  • 201603-03a (63K) – Forever Gold 24K, Forever Gold, Stealth, Time 3, SS Brackets/Metal Brackets; Mini Standard Edgewise, Mini Tweed
  • 201603-03b (66K) – Empower, Master Series, Self Ligating Brackets
  • 201603-03c (68K) – Low Profile (LP) System
  • 201603-03d (69K) – Mini Master Series, Empower 2

BUCCAL TUBES — EU/CE Class IIa

BANDS — EU/CE Class IIa

  • 201603-05a (61K) – MRX Bands, Maximum Retention - MR, Contoured
  • 201603-05b (58K) – Rollo Bands, Band Material
  • 201603-05c (56K) – Anteriors, Mini Skirt Crowns

WIRES (SPRINGS) — EU/CE Class IIa

  • 201603-06a (62K) – Nickel Titanium (NiTi) Memory Springs, Stainless Steel Springs, Kilroy Spring, Uprighting Spring with Safety Hold, Separating Spring
  • 201603-06b (58K) – Rotation Spring, Compliance Spring, Self-Locking Separating Spring, Auxiliary Light Torquing Arch, Power Pin

LINGUAL ATTACHMENTS — EU/CE Class IIa

  • 201603-07a (55K) – Elastic Lugs, Buttons
  • 201603-07b (61K) – Lingual Sheaths, Eyelets, Coil Eyelet, Eruption Appliance
  • 201603-07c (58K) – Low Profile Cleats, Gull Wing Cleats, Ball Hooks, Auxiliary Hook, Seating Lugs

STOPS & HOOKS — EU/CE Class IIa

  • 201603-08a (58K) – Ceramic Button, Weldable Hook, Monkey Hook, Arch Lock, Surgical Hooks
  • 201603-08b (57K) – Arch Hook, Round Crimpable Hook, Crimpable Stop, Weldable Stop, Power Hook

FIXED & FUNCTIONAL — EU/CE Class IIa

  • 201603-09a (58K) – Jet Family, Jasper Jumper, Gentle Jumper, Jones Jig, Rapid Molar Intruder, Palatal Arches
  • 201603-09b (59K) – Quad Helix, Intraoral Expansion Screws, M.A.P. - Mini Activator Posturer, Mandibular Advancer, IOA - Inter Occlusal Appliance
  • 201603-09c (61K) – Quick Fix, Alexander Lip Bumper, Lip Bumper, Bondable Space Maintainer, Bindable Retainer
  • 201603-09d (55K) – Bite Blocks, Tongue Director, Diastema

ORTHODONTIC WIRES — EU/CE Class IIa

  • 201603-10a (63K) – Stainless Steel Wire, Multiphase Blue Chromium Cobalt Wire, Force Two Titanium Memory Wire, Ligature Wire
  • 201603-10b (57K) – Kobayashi Hooks, Tanzo, Tritanium, Everbrite Wire, Beta Titanium Wire
  • 201603-10d (65K) – Therma-Ti, Stainless Steel Retainer Wire, Wrap Around Hawley Retainer Form, Ball Retainer Clasps

ELASTOMERCS — EU/CE Class IIa

  • 201603-11a (59K) – The Wildlife Series, CHains, Ligatures, Tubing, E-Z Tie Tubing
  • 201603-11b (58K) – Sea Life Elastics, Separators, Clear Rotation Wedges, Plastic Tie, Arch Wire Sleeve

ADHESIVES — EU/CE Class IIa

  • 201603-12a (59K) – Eagle FlourSure, Eagle MTP, No Mix:30, Bandtite

MOLAR DISTALIZATION — EU/CE Class IIa

  • 201603-13 (58K) – Cantilever Bar Offset, Hanks Telescoping Herbst (HTH), Miniscope Telescoping Herbst, Herbst Appliance, PowerScope, PowerScope 2

EXTRA ORAL SUPPLY, SUPPLIES — EU/CE Class I

  • 201603-14a (59K) – Cephalometeric Tracing Paper, Orthodontic Wax (Patient Relief Wax), Orthodontic Silicone Wax (Patient Relief Wax), Ortho Wax Bites, Photographic Mirror, Impression Tray, Cheek Retractors
  • 201603-14b (56K) – Laminated Bite Wafers, Impress/Chrome Impression Alginate, Applicator Tips, Elastic Placers, Toothbrushes, Boxes, Ultra-Guard Mouthguard, Protraction Facemask, NOLA Dry Field System, Safety Glasses
  • 201603-14c (58K) – Debond Wafers, UniMarc Arch Wire Markers, Impress/Sure PVS Super Hydrophilic Impression Material, Alginate, Ceka Bond, Medic 365, YC3/Muh Shield, Cotton Roll Holders

EXTRA ORAL SUPPLY, HEAD GEAR — EU/CE Class I

  • 201603-15a (58K) – Safety Release Spring Module, Safety High Pull Headgear Strap, Safety Cervical Neck Strap, Eaglewear
  • 201603-15b (54K) – J-Hook Headcap Assembly, Ortho Band Neck Pads and Straps, 300 Series Facebows, 400 Series Facebows, Protraction Face Mask, Safety Chain

INSTRUMENTS — EU/CE Class I

  • 201603-16a (65K) – Omega, MasterLine, Bracket & Band Placing Instrument, Ligating Instruments
  • 201603-16b (61K) – Debonding Burs, Specialty Instruments
  • 201603-16c (57K) – Empower Instruments, Vision LP Instruments, T3 Instruments, Harmony Instruments
  • 201603-16d (54K) – Wire Bending Pliers, Blue Ray 3, Blue Ray Mini, Luno