Quality & Regulatory Documents

Instructions for Use

We currently support (2) languages in our instructions for use: English and French Canadian.

 

G&H Wire Company Product Revisions
Bands A B C
Aesthetic Brackets A B C
Ligature Wires A B C
Elastomeric Ligature Ties 0 A B
Buccal Tubes A B C
Archwire A B C
Headgear 0 A B
Metal Brackets A B C
Elastomeric Separators A B C
Reverse Pull Face Mask 0 A B
Elastomeric Thread 0 A B
Hooks (weldable and bondable) A B C
Elastics A B C
Metal Self-Ligating Brackets A B C
Springs A B C
Protraction Face Mask 0 A B
Elastomeric Chain 0 A B
Hooks and Stops (Wire or bracket attachments) A B C

 

FlexMedics Product Revisions
Bands 0
Aesthetic Brackets 0
Ligature Wires 0
Elastomeric Ligature Ties 0
Buccal Tubes 0
Archwire 0
Headgear 0 A
Metal Brackets 0
Elastomeric Separators 0
Reverse Pull Face Mask 0 A
Elastomeric Thread 0
Hooks (weldable and bondable) 0
Elastics 0
Metal Self-Ligating Brackets 0
Springs 0
Protraction Face Mask 0 A
Elastomeric Chain 0
Hooks and Stops (Wire or bracket attachments) 0

Quality System Certificates

Notified Body Migration of Certificates

ISO 13485:2016 (MD 635659)

ISO 13485:2016 (MDSAP 695170)

G&H Medical Device Directive 93/42 EEC

G&H ISO 13485:2016

ODP Medical Device Directive 93/42 EEC

ODP ISO 13485:2016

OrthoClub Medical Device Directive 93/42 EEC

OrthoClub ISO 13485:2016

FlexMedics Medical Device Directive 93/42 EEC

FlexMedics ISO 13485:2016

BSI-ISO-13485

Declaration of Conformity

G&H Wire Company Class I

G&H Wire Company Class IIa

ODP Class I

ODP Class IIa

OrthoClub Class I

OrthoClub Class IIa

FlexMedics Class I

FlexMedics Class IIa

Dentsply Retainer Brite

everStick Ortho/A&O

Gestenco Bite Bumper

Gestenco Cheek Retractor

Gestenco Lip Retractor

Gestenco Smartbond®

Great Lakes Orthodontics NOLA products

Ledex Curing Light

Microbrush Corporation

Reliance Class I

Reliance Class IIa

Safety Data Sheets

View Safety Data Sheets

Product Label Symbols

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 Authorized 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-DD, i.e. 2018-03-08.
Manufactured By Manufacturer / “Filled Factory”
Symbol for Manufacturer. May also include the date of manufacture in date format YYYY-MM-DD.
Manufacture Date Manufactured Date / “Open Factory”
Date of manufacture listed under or beside this symbol in YYYY-MM-DD 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.
Instructions for Use Consult electronic Instructions for Use
For products with additional instructions electronically.
Warning Caution/Warning
Consult Instructions for use for important cautionary information such as warnings and precautions not otherwise presented on the label.
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.
Temperature Temperature Upper Limit
Controlled storage is required. Number indicated to the right is the max (highest) temperature at which device should be stored in, or exposed to.
Temperature Temperature Lower Limit
Controlled storage is required. Number indicated to the left is the min (lowest) temperature at which device should be stored in, or exposed to.
Temperature Temperature Limit
Controlled storage is required. Number indicated to lower left is the min (lowest) temperature, and number indicated to upper right is the max (highest) temperature at which the device should be stored in, or exposed to.
Medical Device Medical Device
This symbol indicates the product is a medical device.
CE CE Mark
European Conformance to Medical Device Directive 93/42/EEC or European Conformance to Medical Device Regulation 2017/745

2797

Notified Body Identification Number
BSI Group The Netherlands B.V.
Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, Netherlands
Chrome Nickel Nickel and Chromium warning
Caution: Product contains Nickel and 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.
Data Matrix Data Matrix / “Barcode”
Manufacturer code use to contain traceability data of the particular part.
UDI Data Matrix UDI Data Matrix / “UDI Barcode”
Manufacturer Unique Device Identifier “UDI” code used to contain traceability data of the particular part to meet requirement of FDA CFR 820.120
Hooks Hook
Symbol used to identify brackets that have a hook.
MRI Safe MR Safe
Symbol used to identify product is safe to wear during MRI.
MRI Conditional MR Conditional
Symbol used to identify product is safe to wear during MRI but may affect imaging if performed above the neck.

PRODUCT LABEL SYMBOLS & WARNINGS
Doc. No. - REF.90.005.D
Effective Date: 2021-07-29