Amalgam separators
Amalgam separators serve to treat wastewater containing amalgam residues from treatment units in dental practices.
Regulatory framework
Amalgam separators fall under the Ordinance on the determination of the suitability of construction products and construction techniques under water law by means of verifications in accordance with the Building Codes of the federal states (WasBauPVO).
Cf. WasBauPVO, Section 1(1)(d) 'Amalgam separators for dental practices'.
Requirements for amalgam separators are described in DIN EN ISO 11143. However, this is not a harmonised standard under the Construction Products Regulation.
DIBt grants national technical approvals (abZ) in combination with general construction technique permits (aBG) for these systems. The abZ/aBG serve to verify the suitability of the systems both from a construction and water legislation point of view.
Note: Amalgam separators bearing the CE marking under other European Directives (e.g. the Medical Devices Directive or the Machinery Directive) are subject to a national technical approval in combination with a general construction technique permit.
The following approval principles are currently available:
Approval principles for amalgam separators (Zulassungsgrundsätze für Amalgamabscheider)
The approval principles covering this work area are not published, but are made available to the applicants during the procedure.
pdf-Datei Empfehlungen zum Anschluss von Amalgamabscheidern – Bemessung und Anschlussbedingungen (4 pages ) Stand: März 2020 pdf-Datei Empfehlungen Umgang mit Prophylaxepulvern in Verbindung mit Amalgamabscheidern (3 pages ) Stand: Oktober 2018 pdf-Datei Empfehlungen zur Instandhaltung von Abwasserleitungen in Zahnarztpraxen (4 pages ) Stand: Oktober 2018National procedure
A national technical approval (abZ) and/or oder general construction technique permit (aBG) is granted upon application (see Model Building Code (MBO), Sections 16a(2) and18(2) and (4)). This also applies to amendments and supplements to, or renewals of existing approvals and/or construction technique permits.
No formal requirements apply. The following information is needed: name and address of the applicant, description of the product and/or construction technique and its field of use or application, type of decision required (new decision, amendment or supplement to, or renewal of, an existing decision).
Please feel free to use the template below.
- pdf-Datei Application for a national technical approval and/or construction technique permit (4 pages ) Version: 10 April 2024; Application form
- pdf-Datei Application for amendment / supplementation / renewal of a national technical approval and/or construction technique permit (4 pages ) Last updated: 10 April 2024; Application form
- pdf-Datei Guideline: How to provide drawings for national technical approvals and general construction technique permits (5 pages ) Version: July 2017
| Subject concerned | Applicant | Decision no. |
Validity
from / to |
|---|---|---|---|
| Amalgamabscheider D 3181 II mit Stabankermotor | SIRONA Dental Systems GmbH Fabrikstraße 31 64625 Bensheim | Z-64.1-14 |
Z:
16.01.2024 G: 12.01.2029 |
| Amalgamabscheider in Kombinationssaugeinheit VSA 300 S, Typ 7125 | DÜRR DENTAL SE Höpfigheimer Straße 17 74321 Bietigheim-Bissingen | Z-64.1-15 |
Z:
22.05.2024 G: 03.06.2029 |
| Amalgamabscheider Typ D 3181 II | SIRONA Dental Systems GmbH Fabrikstraße 31 64625 Bensheim | Z-64.1-16 |
Z:
22.07.2020 G: 01.08.2025 |
| Amalgamabscheider COMPACT Dynamic | METASYS Medizintechnik GmbH Florianistraße 3 6063 Rum/Innsbruck ÖSTERREICH | Z-64.1-2 |
Z:
22.03.2022 G: 22.03.2027 |
| Amalgamabscheider CAS 1 Combi-Separator, CA 1 Amalgam-Separator und CA 2 Amalgam-Separator Basisgerät | DÜRR DENTAL SE Höpfigheimer Straße 17 74321 Bietigheim-Bissingen | Z-64.1-20 |
Z:
14.03.2024 G: 19.03.2029 |
| Amalgamabscheider Typ CA 4 | DÜRR DENTAL SE Höpfigheimer Straße 17 74321 Bietigheim-Bissingen | Z-64.1-22 |
Z:
11.11.2020 G: 15.11.2025 |
| Amalgamabscheider Hydrozyklon ISO 18 | CATTANI Deutschland Helmes GmbH & Co. KG Scharnstedter Weg 34-36 27639 Wurster Nordseeküste (Nordholz) | Z-64.1-23 |
Z:
03.03.2022 G: 15.03.2027 |
| Amalgamabscheider D 3521 | SIRONA Dental Systems GmbH Fabrikstraße 31 64625 Bensheim | Z-64.1-24 |
Z:
27.04.2023 G: 15.05.2028 |
| Amalgamabscheider Typ Hydrozyklon ISO 6 | CATTANI Deutschland GmbH & Co. KG Scharnstedter Weg 34-36 27639 Wurster Nordseeküste (Nordholz) | Z-64.1-25 |
Z:
02.12.2019 G: 05.12.2024 |
| Amalgamabscheider Typ Hydrozyklon ISO 60 | CATTANI Deutschland Helmes GmbH & Co. KG Scharnstedter Weg 34-36 27639 Wurster Nordseeküste (Nordholz) | Z-64.1-28 |
Z:
11.07.2022 G: 11.07.2027 |
| Amalgamabscheider Multi System Typ 1 | METASYS Medizintechnik GmbH Florianistraße 3 6063 Rum/Innsbruck ÖSTERREICH | Z-64.1-4 |
Z:
22.03.2022 G: 22.03.2027 |
| Amalgamabscheider SRAB 99 D | medentex GmbH Piderits Bleiche 11 33689 Bielefeld | Z-64.3-17 |
Z:
11.11.2020 G: 25.11.2025 |
| Amalgamabscheider Typ AMALSED | medentex GmbH Piderits Bleiche 11 33689 Bielefeld | Z-64.3-21 |
Z:
24.09.2024 G: 18.09.2029 |
| Amalgamabscheider ECO II und ECO II+ | METASYS Medizintechnik GmbH Florianistraße 3 6063 Rum/Innsbruck ÖSTERREICH | Z-64.3-26 |
Z:
15.03.2023 V: 15.03.2023 G: 15.03.2028 |