AmGraft®

AmGraft® is a dentin matrix, which is made from human teeth. It is produced in chip form between 500–1000 microns and provided freeze dried and sterile.

Product description from the AmGraft® Instructions for Use (date of information 2022-06).

Reference · AM025

AmGraft®

A dentin matrix made from human teeth, supplied as freeze-dried, sterile chips.

Form
Chips, 500–1000 µm Source: IFU p.1
Pack
AM025 · 4 × 0.25 cc Source: Cat. v5.0
Sterilisation
Ethylene oxide Source: IFU p.3
Storage
Clean, dry, 10–30 °C Source: IFU p.3
Use
Single patient; permanent implantation Source: IFU p.2
Manufacturer
Ventas Bio Pte Ltd, Singapore Source: IFU p.3
IFU 2022-06 · Catalogue v5.0

Use and supply

Intended useTo fill and/or augment bony voids or gaps in dentoalveolar surgery IFU
Clinical usesFive, listed in the IFU. Professional area
ManufacturerVentas Bio Pte Ltd, 2 Tukang Innovation Grove #07-02, JTC Medtech Hub, Singapore 618305
Distributor and exporterSanté Maison Pte. Ltd.
IndonesiaKemenkes AKL 20602420387, Class C
SingaporeSee regulatory information
Instructions for UseLatest IFU, date of information 2022-06, in the professional area

AmGraft® is restricted to use by a licensed clinician.

Actual size

0.5–1.0 mm

Measured, not described: the length of an AmGraft® chip, as the Instructions for Use give it.1 The red mark below stands at that length, in its true place on the scale.

  1. AmGraft® Instructions for Use, date of information 2022-06, p.1, “Product Description”: “chip form between 500-1000 microns”. Catalogue v5.0 gives 0.5–1.0 mm.

Calibrate your screen

Hold a bank or ID card flat against the outline and adjust until its edges meet the card’s. The setting stays on this device only.

1 mm = 3.78 px · not calibrated (CSS reference millimetre)

Millimetre ruler drawn at true scaleA scale from 0 to 360 millimetres. The range from 0.5 to 1.0 millimetre, the chip size stated in the AmGraft Instructions for Use, is marked in red. Chip outlines above the scale are drawn at physical size.0.5–1.0 mm0102030405060708090100110120130140150160170180190200210220230240250260270280290300310320330340350360mm
Actual size. Once calibrated, 1 mm on this scale is 1 mm on your screen. The dots above the scale are chip outlines at physical size.

Indications, handling and documents

The five IFU clinical uses, contraindications, precautions, handling steps, storage and the IFU itself are in the professional area. You will be asked to confirm that you are a healthcare professional.

General enquiry