Certificates & approvals

Evidence of conformity for our dental alloys – to download and forward to your authority, your dealer or your quality department.

realloy is the dental brand of realloy e.K., Krefeld. The legal manufacturer within the meaning of MDR (EU) 2017/745 is German Special Alloys GmbH, Willich.

Regulatory evidence

CE · MDR (EU) 2017/745

Notified Body confirmation letter

TÜV NORD CERT GmbH (Notified Body 0044) confirms the formal MDR application and the written agreement pursuant to Art. 120(3c) MDR for the manufacturer German Special Alloys GmbH. The letter covers all realloy alloys, blanks, powders, universal solder and laser welding wire (Class IIa) – transition period until 31 December 2028.

EC certificate 93/42/EEC Annex V, No. 44 235 151578 · Rev. 05 of 16 September 2026 · PDF, English

FDA · USA

FDA Establishment Registration

realloy e.K. is registered with the U.S. Food and Drug Administration as a medical device establishment. You can view the current entry directly in the FDA database.

Registration / FEI No. 3020195105 · Owner/Operator No. 10082496 · Status: Active

Safety data sheets

Powders – cobalt-based

realloy classic Powder, realloy C Powder, realloy BC Powder

Material Safety Data Sheet, Rev. 01 (04/2024) · PDF, English

Powders – nickel-based

realloy N+ Powder (GS-Alloy 5010 N+ Powder)

Safety Data Sheet, Rev. 01 (06/2025) · PDF, German

Casting alloys & blanks

Non-precious dental alloys realloy classic, C, CH, BC, Ga280, LFC, N, N+, Base, modell EH/FH

Safety data sheet (archive, 2017) · PDF, German

Further documents

Instructions for use and data sheets are available directly with each product under "Downloads". We are happy to send declarations of conformity and further evidence on request – just write to info@realloy.net.

Non-precious dental alloys made in Germany.

Legal

Contact

realloy e.K. Moerser Str. 232 47803 Krefeld, Germany Phone +49 2151 486 49 78 info@realloy.net