Align Technology Has Received CE Mark In Europe For The Invisalign Palatal Expander System
Align Technology Has Received CE Mark In Europe For The Invisalign Palatal Expander System
The Invisalign Palatal Expander System is a modern and innovative direct 3D printed device based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition during treatment of patients.- Invisalign Palatal Expanders offer doctors a removeable, safe, and clinically effective alternative to traditional palatal expanders.
- With Invisalign First aligners and Invisalign Palatal Expanders, Align Technology now provides doctors with a full early intervention treatment solution, including both skeletal (orthopedic) and dental (orthodontic) arch expansion.
- The Invisalign Palatal Expander System has also completed registration with the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA).
- Both approvals are for broad patient applicability, including growing children, teens, and adults (with surgery or other techniques).
- Invisalign 擴弓器爲醫生提供了一種可拆卸、安全、臨床有效的替代傳統擴弓器的選擇。
- 通過 Invisalign First 矯正器和 Invisalign 擴弓器，艾利科技現在爲醫生提供一整套早期干預治療解決方案，包括骨骼（矯形）和牙齒（正畸）弓形擴展。
- Invisalign 擴弓器系統已完成與英國藥品和健康產品監管局（MHRA）的註冊。
- 這兩項批准適用於廣泛的患者，包括正在成長的兒童、青少年和成人（通過手術或其他技術）。
Align Technology, Inc. ("Align") (NASDAQ:ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign System of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced that it has received CE Mark in Europe under the Medical Device Regulation (MDR 2017/745) for Align's Invisalign Palatal Expander System. The Invisalign Palatal Expander System has also completed registration with MHRA for the United Kingdom and overseas territories.
艾利科技公司（"艾利"）(納斯達克:ALGN)是一家領先的全球器械公司，設計、製造並銷售 Invisalign 清晰矯正器、iTero 口內掃描儀和 exocad CAD/CAM 軟件，爲數字正畸和修復牙科服務，今天宣佈已在歐洲根據器械法規（MDR 2017/745）獲得 CE 認證，適用於艾利的 Invisalign 擴弓器系統。Invisalign 擴弓器系統還已完成與 MHRA 的註冊，適用於英國及境外地區。
Both approvals are for broad patient applicability, including growing children, teens, and adults (with surgery or other techniques).
這兩項批准適用於廣泛的患者，包括正在成長的兒童、青少年和成人（通過手術或其他技術）。
These approvals mark a significant milestone in Align's efforts to enhance clinical outcomes and efficiency in orthodontics.
這些批准標誌着艾利在提升正畸治療臨床結果和效率方面的重要里程碑。
The Invisalign Palatal Expander System is a modern and innovative direct 3D printed device based on proprietary and patented technology. Invisalign Palatal Expanders are intended for use in rapid expansion and subsequent holding of skeletal and/or dental narrow maxilla (upper jaw) with primary, mixed, or permanent dentition during treatment of patients.
Invisalign 擴弓器系統是基於專有和專利技術的現代創新直接 3D 打印設備。Invisalign 擴弓器旨在快速擴展並隨後保持骨骼和/或牙齒狹窄上頜（上頜）在患者治療期間的初級、混合或恒牙。
譯文內容由第三人軟體翻譯。
