YY/T 1779-2021Dentistry-Orthodontic anchor screws (English PDF)
牙科学 正畸支抗钉
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 9, 2021
Implementation date
April 1, 2022
Scope
YY/T 1779-2021 is the English-translated version of 牙科学 正畸支抗钉.
YY/T 1779-2021 is the Chinese pharmaceutical industry standard for orthodontic anchor screws, the threaded metal screws driven into the jaw to provide temporary skeletal anchorage during orthodontic treatment and removed at the end of it.
It sets the performance requirements, the test methods, and the packaging and labelling information, covering the materials and their corrosion resistance, the dimensions and the thread, the torsional strength and the insertion and removal torque, the surface condition, sterility where the screw is supplied sterile, and the biological evaluation. Issued on 9 March 2021, it has applied since 1 April 2022.
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Document preview — YY/T 1779-2021
National Standard of the People's Republic of China
- Classification
- C 33
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard uses the redrafting method with reference to ISO 19023:2018 ``Dental Orthodontic Anchor Nails'', which is consistent with ISO 19023:2018. The degree of consistency is non-equivalent.
Please note that certain contents of this standard may involve patents. The issuing organization of this standard does not bear the responsibility for identifying these patents.
Introduction
Orthodontic anchorage nail is an auxiliary orthodontic device used to provide temporary bony anchorage for orthodontic tooth movement.
Orthodontic anchor nails are dental medical devices, which are different from dental implants that are permanently implanted in the bone and need to be removed after orthodontic treatment.
This standard does not include the qualitative and quantitative requirements for possible biological hazards, but it is recommended to refer to the
1 Scope
This standard specifies the performance requirements, test methods, packaging and labeling information of anchor nails for orthodontic treatment.
This standard applies to a metal orthodontic anchor nail with a threaded design for connecting bone tissue for orthodontic treatment.
Note. Orthodontic anchorage nails are used in orthodontic treatment to provide temporary intraoral bony anchorage and will be removed after the orthodontic treatment. Similar to intraosseous dental implants, positive The threaded part of the orthodontic anchor screw is screwed into the maxillofacial bone structure.
2 Normative references
The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.
GB 4234 (all parts) Metallic materials for surgical implants
GB/T 4698 (all parts) Sponge titanium, titanium and titanium alloy chemical analysis method
GB/T 7408 Data element and exchange format information exchange date and time representation
GB/T 9937 (all parts) oral vocabulary
GB/T 13810 Titanium and titanium alloy processed materials for surgical implants
GB 23102 Ti-6Al-7Nb alloy processing material for surgical implant metal material
YY 0605.9 Metallic materials for surgical implants
YY/T 1506-2016 Test method for torque of metal bone screws for surgical implants
3 Terms and definitions
The following terms and definitions defined in GB/T 9937 apply to this document.
3.1 Orthodontic anchorage nail
A screw that provides temporary bony anchorage for orthodontic tooth movement.
3.2 Shaft
The part of the orthodontic anchor screw screwed into the bone includes at least the threaded area.
3.3 Head
The area where the orthodontic anchor nail is connected to the orthodontic augmentation device.
3.4 Neck
Orthodontic anchorage is the perforating area between the nail shaft and the head.
3.5 Insertionmode
The way the orthodontic anchor screw is screwed into the bone.
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 7408Date and time - Representations for information interchange - Part 1: Basic rules
- GB/T 9937Dentistry - Vocabulary
- GB/T 13810Wrought titanium and titanium alloys for surgical implants
- GB 23102Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy
- YY 0605.9Implants for surgery—Metallic materials - Part 9: Wrought high nitrogen stainless steel
- YY/T 1506-2016Implants for surgery—Test method for driving torque of metallic bone screws
GB 4234 · GB/T 4698
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Related Standards
GB 23102-2008 — Implants for surgery -- Metallic materials -- Wrought titanium -6aluminium-7niobium alloy
GB 4234.1-2017 — Implants for surgery—Metallic materials—Part 1: Wrought stainless steel
GB 4234.1-2026 — Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
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YY/T 1779-2021
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