Therapeutic Goods Order No. 67 Standard for Dental Materials (23/02/2001) (Cth)
Therapeutic Goods Order No. 67 - Standard for Dental Materials
as amended
made under section 10 of the
Therapeutic Goods Act 1989
This compilation was prepared on 9 May 2007
taking into account amendments up to Therapeutic Goods Order No. 67A - Amendment to Therapeutic Goods Order No. 67 - Standard for Dental Materials
Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra
Therapeutic Goods Order No. 67
Standard for Dental Materials
I, TERRY SLATER, delegate of the Minister of State for Health and Aged Care for the purposes of section 10 of the Therapeutic Goods Act 1989 and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with section 10 of the said Act, HEREBY:
(1) REVOKE Therapeutic Goods Order No. 57 “Dental Materials”, signed by the delegate on 7 April 1997 and gazetted on 23 April 1997; and
(2) DETERMINE THAT:
(a) the matters specified in each of the International Standards made and published by the International Organisation for Standardisation, listed in Column 1 of the Schedule to this Order, constitute a standard for the therapeutic goods, or class of therapeutic goods, described in Column 2 of the Schedule in relation to that International Standard; and
(b) the International Standards ISO 9917:1991(E) Dental water‑based cements and ISO 9917‑2:1998(E) Dental water‑based cements – Part 2: Light‑activated cements shall both constitute the standard for water=based dental cements, subject to the following modification:
(i) Subclause 8.2 (Marking) of ISO 9917:1991 (E) Dental water‑based cements, shall be omitted and replaced with the following new subclause 8.2:
“8.2 Marking
The requirements of Therapeutic Goods Order No. 37 General Requirements for Labels for Therapeutic Devices shall apply.” ; and
(ii) Subclause 8.2 (Marking) of ISO 9917‑2 1998(e) Dental water‑based cements – Part 2: Light‑activated cements, shall be omitted and replaced with the following new subclause 8.2:
“8.2 Marking
The requirements of Therapeutic Goods Order No 37 General Requirements for Labels for Therapeutic Devices shall apply.”
This Order commences on the date this Order is gazetted in the Commonwealth Gazette.
Schedule Dental Materials
| Column 1 Standard | Column 2 Goods |
| ISO 1559-1995 (E) | Alloys for dental amalgam |
| ISO 1560 – 1985 (E) | Dental mercury |
| ISO 6876 – 1986 (E) | Dental root canal sealing |
| ISO 3107: 1988 (E) | Dental zinc oxide/eugenol |
| ISO 6874: 1988 (E) | Dental resin‑based pit |
| ISO Standard 4049: 2000 Dentistry – Polymer-based filling, restoration and luting materials, Third edition | Polymer-based filling, restoration and luting materials |
Notes to the Therapeutic Goods Order No. 67 - Standard for Dental Materials
Note 1
The Therapeutic Goods Order No. 67 - Standard for Dental Materials in force under section 10 of the Therapeutic Goods Act 1989 as shown in this compilation is amended as indicated in the Tables below.
Table of Instruments
| Title | Date of notification | Date of | Application, saving or |
| Therapeutic Goods Order No. 67 – Standard for Dental Materials (F2007B00467) | 14 Mar 2001 (see Gazette 2001, No. GN10) | 14 Mar 2001 | |
| Therapeutic Goods Order No. 67A – Amendment to Therapeutic Goods Order No. 67 – Standard for Dental Materials (F2007B00466) | 14 Aug 2002 (see Gazette 2002, No. GN32) | 14 Aug 2003 | — |
Table of Amendments
| ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted | |
| Provision affected | How affected |
| Schedule | |
| Schedule................................ | am. Order No. 67A |
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