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YY/T 1779-2021 English PDF

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YY/T 1779-2021: Dentistry - Orthodontic anchor screws
Status: Valid
Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 1779-2021209 Add to Cart 3 days Dentistry - Orthodontic anchor screws Valid

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Basic data

Standard ID: YY/T 1779-2021 (YY/T1779-2021)
Description (Translated English): Dentistry - Orthodontic anchor screws
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Word Count Estimation: 11,187
Issuing agency(ies): State Drug Administration

YY/T 1779-2021: Dentistry - Orthodontic anchor screws

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Dentistry - Orthodontic anchor screws ICS 11.060.10 C33 People's Republic of China Pharmaceutical Industry Standards Dental orthodontic anchor nail Released on 2021-03-09 2022-04-01 implementation Issued by the National Medical Products Administration

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. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Standardization Technical Committee for Dental Materials and Devices (SAC/TC99). Drafting organizations of this standard. Peking University School of Stomatology Dental Medical Device Inspection Center, Zhejiang Xinya Medical Technology Co., Ltd., Peking University School of Stomatology, Kavac Dental Medical Instruments (Suzhou) Co., Ltd. The main drafters of this standard. Li Yuan, Lin Hong, Chen Xianming, Chen Gui, Zeng Jiajia.

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 GB/T 16886.1 and YY/T 0268. Dental orthodontic anchor nail

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 article Pieces. 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. Part 9.Forged high-nitrogen stainless steel 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 orthodonticanchorscrew 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.
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