Certificate number:
FM 76230
Scope: The manufacture, distribution and servicing of orthodontic products including: bonding adhesives, primers and cements, etchants, metal brackets, archwires, buccal tubes, bands, ceramic brackets, curing lights, facebows and traction devices, silver solders, instruments, progressive orthodontic appliance systems, orthodontic accessories; and intraoral force products including: elastomerics, nitinol springs, stainless steel springs.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| ISO 13485:2016 |
2003-06-24 |
2027-07-05 |
Certificate number:
MDSAP 680902
Scope: The manufacture, distribution and servicing of orthodontic products including: bonding adhesives, primers and cements, etchants, metal brackets, archwires, buccal tubes, bands, ceramic brackets, curing lights, facebows and traction devices, silver solders, instruments, progressive orthodontic appliance systems, orthodontic accessories; and intraoral force products including: elastomerics, nitinol springs, stainless steel springs.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| MDSAP |
2018-07-06 |
2027-07-05 |
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| (EU) 2017/745 Annex IX Chapter I and III |
2024-02-07 |
2029-02-06 |
Certificate number:
MD 814815
Scope: The design and development, manufacture, distribution and servicing of orthodontic products including: bonding adhesives, primers and cements, etchants, metal brackets, archwires, buccal tubes, bands, ceramic brackets, curing lights, facebows and traction devices, silver solders, instruments, progressive orthodontic appliance systems, orthodontic accessories; and intraoral force products including: elastomerics, nitinol springs, stainless steel springs.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| ISO 13485:2016 |
2024-08-21 |
2027-07-05 |
Certificate number:
MDSAP 814817
Scope: The design and development, manufacture, distribution and servicing of orthodontic products including: bonding adhesives, primers and cements, etchants, metal brackets, archwires, buccal tubes, bands, ceramic brackets, curing lights, facebows and traction devices, silver solders, instruments, progressive orthodontic appliance systems, orthodontic accessories; and intraoral force products including: elastomerics, nitinol springs, stainless steel springs.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| MDSAP |
2024-08-21 |
2027-07-05 |
Certificate number:
CE 00733
Scope: The manufacture of orthodontic wires, metal brackets, ceramic brackets, buccal tubes, bands and attachments, band cements, primers, bonding adhesives, elastomeric auxiliaries and intraoral attachments.
Those aspects of Annex V related to accuracy of metrology in the manufacture of orthodontic measuring gauges.
| Standard/Scheme number or name |
Start Date |
Expiry Date |
| 93/42/EEC Annex V, Section 3.2 (2007/47) |
1995-06-27 |
2024-05-26 |
