AmGraft® AM025Dentin matrixIFU 2022-06

What the tooth was, the bone can become.

Every tooth keeps a record: of growth, of strength, of the bone that held it. AmGraft® gathers that record, quietly, and gives it back to the place it came from.

General enquiry

Dentin matrix 0.5–1.0 mm chips Made by Ventas Bio Pte Ltd, Singapore Distributed by Santé Maison For licensed clinicians Sources

Figure 1: the first 1.5 millimetres of a scale, enlarged. A shaded band marks 0.5 to 1.0 millimetre, the chip length stated in the AmGraft Instructions for Use. Four chip outlines aligned at zero each end inside the band.0.5–1.0 mmIFU chip length00.51.01.5 mm
Fig. 1 The first 1.5 mm of a scale, enlarged. The shaded band is the chip length stated in the IFU. Outlines are drawn, not photographed.
Sources (3)
  1. AmGraft® Instructions for Use (IFU), date of information 2022-06, p.1, “Product Description”: “a dentin matrix, which is made from human teeth … produced in chip form between 500-1000 microns”.
  2. IFU p.3, “Manufacturer”: Ventas Bio Pte Ltd, JTC Medtech Hub, Singapore. Santé Maison Pte. Ltd. distributes and exports AmGraft®.
  3. IFU p.1, “Precautions”: “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.

The record

A material should be able to show its papers. The front of this card holds what the IFU and the catalogue state; turn it over to see where each line was written.

Each strip, part number AM025, holds four portions of 0.25 cc. Source: Cat. v5.0

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

Latest from the journal

Reading notes on bone grafting, from the empty socket to the registration file. Each article lists its sources.

Regulation

Reading a bone graft’s registration: what HSA notification and Indonesian izin edar mean

Human-tissue grafts in Singapore are notified to HSA as Class 1 CTGTP; in Indonesia every imported device needs an izin edar. What each means, how to check it, and what it does not tell you.

Clinical practice

Healing time after bone grafting: reading the AmGraft IFU’s six-month minimum

The AmGraft IFU recommends at least six months of healing at the augmented site. How that sits beside...

Tooth-derived grafts

Tooth-derived bone grafts explained: what the autogenous dentin studies show

Two meta-analyses of autogenous dentin grafts in ridge preservation, how dentin grafts are classified, and why results from...

Clinical practice

Socket preservation after extraction: what the evidence supports

Ridge preservation reduces post-extraction bone loss in most trials, but the certainty of evidence and the long-term benefit...

Where it is supplied

Made in Singapore, supplied in Singapore and Indonesia. Each registration can be checked where it was issued.

Singapore

UEN 202440255D

Santé Maison Pte. Ltd., 24 New Industrial Rd. Source: ACRA AmGraft® is manufactured by Ventas Bio Pte Ltd at the JTC Medtech Hub. Source: IFU p.3

Singapore regulatory status

Indonesia

AKL 20602420387

Class C, registrant PT Global Sarana Trading, valid until 14 May 2027. Exported by Santé Maison. Source: Kemenkes AKL record

Indonesian registration details

Contact

Write, call, or find us in Singapore.