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.
Principles, guidance, recommendations
The approval principles covering this work area are not published, but are made available to the applicants during the procedure.
The following approval principles are currently available: Approval principles for amalgam separators (Zulassungsgrundsätze für Amalgamabscheider)
Empfehlungen zum Anschluss von Amalgamabscheidern – Bemessung und Anschlussbedingungen (4 pages)Stand: März 2020
Empfehlungen Umgang mit Prophylaxepulvern in Verbindung mit Amalgamabscheidern (3 pages)Stand: Oktober 2018
Empfehlungen zur Instandhaltung von Abwasserleitungen in Zahnarztpraxen (4 pages)Stand: Oktober 2018
Application forms
National 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.
Application for a national technical approval and/or construction technique permit (3 pages)Version: January 2018; Application form
Application for amendment / supplementation / renewal of a national technical approval and/or construction technique permit (4 pages)Version: January 2018; Application form
Guideline: How to provide drawings for national technical approvals and general construction technique permits (5 pages)Version: July 2017
- abZ/aBG
Z = new decision | E = supplement | Ä = amendment | V = renewal | G = valid until Subject concerned Applicant Decision no. Validity
from / toAmalgamabscheider D 3181 II mit Stabankermotor SIRONA Dental Systems GmbH
Fabrikstraße 31
64625 Bensheim
Z-64.1-14 Z: 09.01.2019
G: 11.01.2024Amalgamabscheider in Kombinationssaugeinheit VSA 300 S, Typ 7125 DÜRR DENTAL SE
Höpfigheimer Straße 17
74321 Bietigheim-Bissingen
Z-64.1-15 Z: 23.05.2019
G: 02.06.2024Amalgamabscheider Typ D 3181 II SIRONA Dental Systems GmbH
Fabrikstraße 31
64625 Bensheim
Z-64.1-16 Z: 22.07.2020
G: 01.08.2025Amalgamabscheider COMPACT Dynamic METASYS Medizintechnik GmbH
Florianistraße 3
6063 Rum/Innsbruck
ÖSTERREICH
Z-64.1-2 Z: 22.03.2022
G: 22.03.2027Amalgamabscheider 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: 27.03.2019
G: 18.03.2024Amalgamabscheider Typ CA 4 DÜRR DENTAL SE
Höpfigheimer Straße 17
74321 Bietigheim-Bissingen
Z-64.1-22 Z: 11.11.2020
G: 15.11.2025Amalgamabscheider 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: 15.03.2027Amalgamabscheider D 3521 SIRONA Dental Systems GmbH
Fabrikstraße 31
64625 Bensheim
Z-64.1-24 Z: 03.05.2018
G: 14.05.2023Amalgamabscheider 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: 05.12.2024Amalgamabscheider 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: 11.07.2027Amalgamabscheider Multi System Typ 1 METASYS Medizintechnik GmbH
Florianistraße 3
6063 Rum/Innsbruck
ÖSTERREICH
Z-64.1-4 Z: 22.03.2022
G: 22.03.2027Amalgamabscheider SRAB 99 D medentex GmbH
Piderits Bleiche 11
33689 Bielefeld
Z-64.3-17 Z: 11.11.2020
G: 25.11.2025Amalgamabscheider Typ AMALSED medentex GmbH
Piderits Bleiche 11
33689 Bielefeld
Z-64.3-21 Z: 09.09.2019
G: 17.09.2024Amalgamabscheider ECO II METASYS Medizintechnik GmbH
Florianistraße 3
6063 Rum/Innsbruck
ÖSTERREICH
Z-64.3-26 Z: 17.09.2020
V: 23.02.2021
G: 24.02.2026