Vietnam MOH registration 2403323ĐKLH/BYT-HTTB

Bone resorption membrane

VN: Màng xương tự tiêu

Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Datum Dental LTD·Registered Nov 06, 2024

Registration details

Analysis ID: 2403323ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-201027-0009
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Datum Dental LTD
Manufacturer Country: Theo theo phụ lục
Product Owner: Datum Dental LTD
Authorized Representative: CÔNG TY TNHH Y NHA KHOA 3D

Technical details

Intended Use: The bone membrane is a self-dissolving collagen membrane used in guided bone and guided tissue regeneration procedures, where the bone membrane acts as a biological degradation barrier: 1. Dental implant surgery. 2. For bone-implanted teeth with vertical bone loss due to infection, only in cases where the required surface treatment of the bone-implanted tooth can be achieved. 3. Bone grafting in the compromised area around the bone-implanted tooth. 4. Regeneration of bone defects in the maxilla or mandible. 5. Guided tissue regeneration or guided tissue repair. 6. Open or closed sinus lift surgery in the maxilla. 7. Bone conservation surgery after tooth extraction. 8. Periodontal surgery.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Bone resorption membrane in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403323ĐKLH/BYT-HTTB and manufactured by Datum Dental LTD. The authorized representative in Vietnam is CÔNG TY TNHH Y NHA KHOA 3D.

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