Quality Policy

Orthodontic Design and Production, Inc. strives to deliver a best in class customer experience by offering high quality orthodontic appliances on time, without defects and competitively priced.

Our dedicated team of professionals are trained to maintain and continually improve the effectiveness of our quality management system while ensuring compliance with applicable standards, regulatory requirements and customer requirements.

This will give our customer base the confidence that they will receive products that are of consistently high quality, with the added assurance that their individual needs and expectations will be met.

Quality System Management

ODP's quality management system is certified to the ISO 9001:2008 and 13485:2003 standards to ensure consistent quality and high customer satisfaction. A quality management system is a common sense, well-documented system that ensures consistency and improvement of working practices, including the products and services produced. Quality management systems are based on standards, which specify a procedure for achieving effective quality management.

ISO standards contribute to making the development, manufacturing and supply of products and services more efficient, safer and cleaner. They make trade between countries easier and fairer. They provide governments with a technical base for health, safety and environmental legislation. They aid in transferring technology to developing countries. ISO standards also serve to safeguard consumers, and users in general, of products and services.

ISO 13485:2003
Effective Quality Management Systems are recognized as a key regulatory consideration for allowing medical device manufacturers to market their products around the world. Whatever devices they produce, medical device manufacturers have a responsibility to consistently deliver devices that are safe and effective. ISO 13485:2003 is the international standard recognized for medical device Quality Management Systems registration.

ISO 13485:2003 provides a good base model for compliance with the EU CE marking Medical Devices Directives (Annex II, V, VI), Japan Pal and Health Canada CMDCAS (class II, III & IV devices) requirements. ISO 13485:2003 is also considered to be fully compatible with the FDA QSR.

Click here to view ODP's ISO 9001:2008 certificate in PDF format. Adobe Acrobat PDF
Click here to view ODP's ISO 13485:2003 certificate in PDF format. Adobe Acrobat PDF


CE Mark for EU Member Countries

The CE mark is the official marking required by the European Community. CE Marking is often referred to as a 'passport' that allows manufacturers from anywhere in the world to sell their goods throughout the European market. In many countries within Europe, where a New Approach Directive is in force, CE Marking is a legal requirement for products, packaging and any accompanying literature. It proves to the buyer or user that the product fulfills all essential safety and environmental requirements as defined in the European Medical Device Directives.

Click here to view ODP's CE certificate in PDF format. Adobe Acrobat PDF

Declarations of Conformity


Food and Drug Administration (FDA)
Certificate to Foreign Government (CFG)

The FDA's mission is to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use. The FDA is a blending law and science aimed at protecting consumers. ODP's quality management system is compliant with the FDA's quality system regulation 21 CFR Parts 808, 812, and 820, Medical Devices; Current Good Manufacturing Practice (cGMP).

Click here to view ODP's FDA certificate to foreign government in PDF format. Adobe Acrobat PDF

Click here to view ODP's FDA registration status.
*Enter ODP's registration no. 2029191 and click on the search button.


Material Safety Data Sheets

In 1988, the Department of Labor passed the Occupational Safety and Health Act (OSHA). In order to ensure chemical safety in the workplace, information must be available about the identities and hazards of the chemicals used in the workplace. OSHA's Hazard Communication Standard (HCS) requires the development and dissemination of such information through Material Safety Data Sheets.

Click here to view the ODP's Material Safety Data Sheets


Product Label Symbols

The information provided below is an explanation of reference symbols that can be found on product labels.
REF
Catalog Number / "Reference"
This symbol immediately precedes the part number of the product.
LOT
Batch Code / "Lot"
This symbol immediately precedes the lot number of the product. G&H uses this for part traceability.
EU REP
Authorised Representative in the European Community / "EU Rep"
This symbol immediately precedes the name of our representative within the member states.
Single Use Only
Do Not Reuse / "Single Use Only"
Devices with this symbol are intended for single use.
Hourglass
Use By / "Hourglass"
This symbol identifies that the part has a "Use by" date. The part should be used prior to the date located next to this symbol. Date format YYYY-MM, i.e. 2013-11.
Manufactured By
Manufacturer / "Filled Factory"
Symbol for Manufacturer. May also include the date of manufacture in date format YYYY-MM.
Manufacture Date
Manufactured Date / "Open Factory"
Date of manufacture listed under or beside this symbol in YYYY-MM format. Note: Used only when the "filled factory" symbol is not present.
Instructions for Use
Consult Instructions for Use / "IFU Book"
For products with additional instructions inside the package.
Non-Sterile
Non-Sterile / "Non-Sterile Triangle"
Not Used: G&H products are sold non-sterile.
Sunlight
Keep away from Sunlight / "Sunlight Warning"
Used on elastics. Product may demonstrate reduced performance / longevity when exposed to sunlight.
Latex
Contains latex or Presence of Natural Rubber Latex / "Latex Warning"
Used on latex elastics.
Trash
Do Not Dispose in Household Trash
Used for products with batteries or electrical components, cords, chargers, etc.
Chrome Nickel
Nickel and/or Chromium warning
Caution: Product contains Nickel and/or Chromium. To alert of the potential for allergic reactions to these known allergens.
Proposition 65
The Safe Drinking Water and Toxic Enforcement Act of 1986 / "Proposition 65"
This product contains chemicals known to the State of California to cause cancer and other birth defects.
Rx Only
For use or distribution by orthodontic professionals only.
Hooks
Hook
Symbol used to identify brackets that have a hook.
Data Matrix
Datmatrix / "Barcode"
Manufacturer code use to contain traceability data of the particular part.
CE
CE Mark
European Conformance to Medical Device Directive 93/42/EEC
CE
CE Class II
Used with the CE mark, the numbers provide reference to our Notified Body. For Indiana, 0120 is used; for California, 0086 is used.
Temperature
Temperature
Used to denote appropriate storage temperatures, when controlled storage is required. Numbers to the left of the symbol are min, or the lowest temperature used in the storage of the device, numbers to the right are max, or the highest temperature used in the storage of the device.
Warning
Warning
See additional symbols / Instructions for use.
Sharp Warning
Sharp
Caution: package contains sharp object.
G&H Logo
G&H Logo
Our logo for the master brand.
ODP Logo
ODP Logo
Our logo for the ODP brand, used for products manufactured out of our California facility.
PRODUCT LABEL SYMBOLS & WARNINGS
Doc. No. - REF.IN.75.11.03.A
Effective Date: October 23, 2013

For more information, please contact:

Mr. Richard Merrell
Regulatory Affairs Manager
Phone Extension 25
rm@ghortho.com


European Representative:
mdi Europa GmbH
Langenhagener Str. 71
30855-Langenhagen Germany
Tel: +49 511 39 08 95 30
Fax: +49 511 39 08 95 39


Note: Some of ODP's products contain small amounts of nickel and/or chromium, which are known to the State of California to cause cancer. A small percentage of the population is known to be allergic to nickel or chromium. If an allergic reaction occurs, direct the patient to consult a physician.