GNI Co., Ltd.

5F 501, 63-12, Dongtancheomdansaneop 1-ro, Hwaseong-si, Gyeonggi-do, Korea

Tel: +82-505-600-8880 / Fax: +82-505-333-8880 / http://www.gniortho.com

Certificate of Analysis

 Orthodontic Ceramic Bracket

1) Material

No. Name of Component Raw material Amount

Bracket Slot Aluminum oxide 99.99%

1 Ceramic Bracket no hook
Bracket Side hook Aluminum oxide 99.99%

Hook Aluminum oxide 99.99%

2 Ceramic Bracket with hook Bracket Slot Aluminum oxide 99.99%

Bracket Side hook Aluminum oxide 99.99%

3 Identification dot Ink Business secret

2) Test

Test Item Evaluation criterial Results

No defects such as abrasion or
Visual Inspection Test contaminant at the surface of the
test sample.
Packing Inspection No defects at the packing of the
(Visual Test) test sample.
Dimensions should be within the
Dimension Test
range of ±5% and ±1°.
The total metal ion release into
the specified solution at (37±) ℃
Corrosion Test
for (7.0±0.1) day shall not
exceed 200 ㎍/cm² .
Ni(Clip): 8.1 – 8.5 wt %
Content for the hazardous elements Cd, Be, Pb: less than 0.02 wt %
Any defects were not observed at
the surface of the test sample.
Any defects at the packing of the
test sample were not observed.
Dimensions were within the range of
length ±5% and ±1°.
The average total metal ion release
from the orthodontic brackets were
41.267 ±2.164㎍/cm² for 7days.
Ni(Clip): 8.256 wt %
Cd, Be, Pb: less than 0. wt %

According to specified control procedures, we certify that all the products comply with all the dimensional, aesthetic
and functional specifications of use.

We also certify that the products described herein are manufactured in accordance with the European Directive
93/42EEC on Medical Devices, and their design, manufacturing and final control are performed according to the
Quality Management Systems ISO 13485.