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)

CERAMIC BRACKETS — EU/CE Class IIa

WIRES (SPRINGS) — EU/CE Class IIa

  • 858.170201 (245K) – Nickel Titanium Memory Springs, NiTi Springs

LINGUAL ATTACHMENTS — EU/CE Class IIa

FIXED & FUNCTIONAL — EU/CE Class IIa

ORTHODONTIC WIRES — EU/CE Class IIa

  • 857.170201 (239K) – Power Pin
  • 858.170201 (245K) – Therma-Ti®, Therma-Ti® Lite, Therma-Ti® "D", Tritanium™, Beta Titanium Wire, Stainless Steel Wire, Force Two NiTi Wire, Gold Tone, Stainless Steel Multi-Strand
  • 859.170201 (262K) – Beta Titanium Wire, Stainless Steel Wire, Stainless Steel Multi-Strand, Force Two NiTi Wire, Gold Tone, Gold Coated, Kobayashi Hooks, Orientation Pin

ELASTOMERCS — EU/CE Class IIa

ADHESIVES — EU/CE Class IIa

  • 856-170201 (246K) – Bandtite™ Band Cement, MR Lock LC™, No Mix: 30™, Eagle FluorSure™, Acid Etching (Gel, Semi-Gel, Liquid), Porcelain Conditioner, Eagle Spectrum™, Eagle No Drift™, Eagle MTP™, Eagle Sealant, Sealant

Declaration of Conformity Certificates

CERAMIC BRACKETS — EU/CE Class IIa

COMPOSITE BRACKETS — EU/CE Class IIa

SS BRACKETS — EU/CE Class IIa

  • 201706-05 (42K) – LP® Low Profile, Empower® 2, Mini Master Series™, Master Series™, T3™, Mini Standard Edgewise, Mini Tweed, Forever Gold™, Forever Gold™ 24K, Metal Custom Rx, Stealth™ Lingual

BUCCAL TUBES — EU/CE Class IIa

  • 201706-05 (47K) – Empower®, Empower® 2, Mini Master Series™, Master Series™, iFit®, LP® Low Profile, Slim Tube™, Cross Tubes, Piggyback Tubes, Dr. Korn Tube, Inconel, Funneled Entrance, Non Convertible, Non Convertible Double, Non Convertible Triple, Non Convertible Lip Bumper, Non Convertible WRAPAROUND, Convertible Single, Convertible Double, Convertible Triple, Nola Buccal Tube, DB Tube Gold

BANDS — EU/CE Class IIa

  • 201706-06 (43K) – MRX Bands, MR, MR1, MR2, MR3, Contoured, Rollo Bands, Anteriors, Band Material, Mini Skirt™ Crowns

WIRES (SPRINGS) — EU/CE Class IIa

  • 201706-07A (42K) – Stainless Steel Springs, Uprighting Spring, Rotation Spring, Compliance Spring, Kilroy Spring, Auxiliary Light Torquing Arch, Ulysses/Extrusion Spring, Nickel Titanium Memory Springs, NiTi Springs
  • 201706-07H (37K) – Nickel Titanium Memory Springs, NiTi Springs

LINGUAL ATTACHMENTS — EU/CE Class IIa

  • 201706-08 (44K) – Buttons, Ball Hooks, Lingual Sheaths, Eyelets, Coil Eyelet, Low Profile Cleats, Gull Wing Cleats, Elastic Lugs, Seating Lugs
  • 201706-08C (38K) – Ceramic Button
  • 201706-08E (37K) – Eruption Appliance

STOPS & HOOKS — EU/CE Class IIa

  • 201706-09 (47K) – Power Hook, Crimpable Stop, Weldable Stop, Surgical Hook, Arch Hook, Arch Lock, Monkey Hook

FIXED & FUNCTIONAL — EU/CE Class IIa

  • 201706-10 (40K) – Distal Jet, Spring Jet, Mesial Jet, Uprighter Jet, Jasper Jumper, Gentle Jumper, Jones Jig™, Rapid Molar Intruder, M.A.P. Mini Activator Posturer, Mandibular Advancer, Quick Fix, Lip Bumper, Bondable Space Maintainer, Bondable Retainer, Bite Blocks, Tongue Director, Diastema, Cantilever Bar Offset, Hanks Telescoping Herbst®, Miniscope™ Telescoping Herbst®, Herbst™ Appliance, Powerscope™ 2
  • 201706-10A (37K) – Palatal Arches
  • 021706-10B (35K) – Quad Helix

ORTHODONTIC WIRES — EU/CE Class IIa

  • 201706-11 (39K) – Tanzo™, NT3™, Superelastic Titanium Memory, Everwhite™ Wire, Wrap Around Hawley Retainer
  • 201706-11A (37K) – Gold Coated, Kobayashi Hooks, Orientation Pin, Beta Titanium Wire, Stainless Steel Wire, Force Two NiTi Wire, Gold Tone, Stainless Steel Mulit-Strand
  • 201706-11G (34K) – Power Pin
  • 201706-11H (37K) – Therma-Ti®, Therma-Ti® Lite, Therma-Ti® "D", Tritanium™, Beta Titanium Wire, Stainless Steel Wire, Force Two NiTi Wire, Gold Tone, Stainless Steel Multi-Strand

ELASTOMERCS — EU/CE Class IIa

  • 201706-12 (43K) – The Wildlife Series™, Sea Life Elastics, Colored Chain, Ligatures, Memory Chain
  • 201706-12E (37K) – Separators

ADHESIVES — EU/CE Class IIa

  • 201706-01F (36K) – Bandtite™ Band Cement, MR Lock LC™, No Mix: 30™, Eagle FluorSure™, Acid Etching (Gel, Semi-Gel, Liquid), Porcelain Conditioner, Eagle Spectrum™, Eagle No Drift™, Eagle MTP™, Eagle Sealant, Sealant

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