Which country are Alpha-Bio implants from?

According to a 2008 industry report based on Haaretz, Alpha-Bio Tec was founded in Israel in 1988 by the dentist Ophir Fromovich; the manufacturer's own documents do not give a founding year. For a time the company was in Petah Tikva, just east of Tel Aviv; even a clinical study published in 2019 gives the manufacturer of the implants used as 'Alpha-Bio Tec, Petach Tikwa, Israel'. The manufacturer's current facility is again in Israel, in the city of Modi'in. The company describes this facility as a production and research site of 86,000 square feet, or about 8,000 square metres.

Ownership changed in 2008. On 7 February 2008 Nobel Biocare announced that it had signed an agreement to buy all the shares in Alpha-Bio Tec, and the deal was expected to be completed in the second quarter of the same year. According to the announcement, Alpha-Bio held more than 60 per cent of the Israeli implant market at the time and its products were sold in more than 40 countries. In 2014 Nobel Biocare passed to the American company Danaher; in 2018 Danaher brought its dental businesses together in a company called Envista, and in 2019 Envista was floated on the stock market and separated from Danaher. This is how Alpha-Bio is today a brand of Envista.

So the answer to the question of which country it is from has two layers. The product's roots, design and production are in Israel; the group that holds the brand is registered in the USA. Envista's annual report states plainly that there is a production facility in Israel belonging to the Alpha-Bio brand. Distribution of the product, meanwhile, is run from a global logistics hub in the Dutch city of Venlo. Where any single implant you are given was made is stated most definitively by the label on its box.

The relationship with Nobel Biocare is often confused. A few months after the acquisition, an official writing on behalf of Alpha-Bio wrote that the two companies would carry on as separate brands, each keeping its own brand identity. Today Envista describes Nobel Biocare as a pioneer of implant science, and Alpha-Bio Tec and Implant Direct as value implant businesses serving different price points. So it is the same group, but two separate product families with different positioning.

There is also a design link between the two brands. In its 2008 announcement, Nobel Biocare introduced Alpha-Bio as the company that developed the product that was the forerunner of NobelActive. This does not mean the two brands sell the same implant today. Line names, connections, surgical kits and prosthetic parts are in separate catalogues; ordering a part for one of them is done by looking at the connection and size information, not the brand name.

Alpha-Bio is not a single implant but a family. The manufacturer's current list includes MultiNeO and MultiNeO NiNA, DFI, SPIRAL, ICE and NICE. The prosthetic parts are grouped into three connection lines: conical standard (CS), conical narrow (CHC) and internal hex (IH). SPI, which comes up often in publications, is an older line and does not appear among the lines the manufacturer highlights today.

The factual answer to the question of whether it is any good is that it is a system that has been made for more than thirty years, is used in many countries and is named in independent publications. In a retrospective study from the Medical University of Łódź in Poland, 480 Alpha-Bio SPI implants placed in 184 patients were followed for 60 months after loading, and no implants were lost. In the same study, the average bone loss around these internal hex implants at 60 months was greater, at 1.30 mm, than that of the conical-connection implants of another brand they were compared with (0.96 mm). The authors attribute the difference to the connection type; however, the two groups consist of implants from different manufacturers and are very different in size (480 against 60), so the difference cannot be put down to the connection alone.

Even so, the brand is the smaller half of the question. Whether an implant stays in the mouth over the years is determined more strongly by planning, how the load is spread, factors such as smoking and uncontrolled diabetes, and regular maintenance. Alpha-Bio's lines are conventional two-piece implants: they sit in the inner part of the bone and need enough volume there. The implant used in the protocol of fixed teeth in 72 hours with the Ihde method belongs to another class: a one-piece corticobasal implant that anchors in the hard outer layer of the jaw.

The points below are not specific to Alpha-Bio; they concern the implant design that sits inside the bone, has two pieces and needs a healing period.

If the answers are short and clear, there is a considered choice behind the plan. Every answer that stays vague is a gap you will have to fill in later.

1. 1

   Which line will be used?

   MultiNeO, MultiNeO NiNA, DFI, SPIRAL, ICE or NICE. It should be possible to explain the choice in terms of the density, width and height of your bone and, if there is an extraction socket, its condition.

2. 2

   What is the connection type?

   Conical standard (CS), conical narrow (CHC) or internal hex (IH). The top parts, and every future replacement of a screw or part, depend on this answer.

3. 3

   Are the top parts original?

   The manufacturer's own parts and parts sold by other companies as compatible are not the same thing. You should be told which one is used, and it should go on the record.

4. 4

   Can I see the barcode on the label?

   Medical devices put on the market in Turkey must be registered in the Product Tracking System (ÜTS). The number on the label shows the product's manufacturer and its record; this is a more concrete check than anything you hear about the brand.

5. 5

   What does the manufacturer's warranty cover?

   Alpha-Bio announces a lifetime warranty programme for its implants: replacement of the implant with a new one in the event of a product defect, failure of the implant to integrate, fracture or contamination. The programme is granted to the first purchaser, which is usually the clinic, and the text makes no mention of the cost of labour or retreatment. Ask the clinic separately who will cover that cost.

If the first four points below are in place, the difference between brands narrows; if they are not, no brand makes up for the shortfall.

A few misleading shortcuts circulate around a brand that has changed hands twice.

Nobody asks for these documents today; but years from now, in another dentist's chair, they are the first thing you will be asked for.

1. An implant card showing the line and connection

   The card should say more than just 'Alpha-Bio'; it should show the line name, connection type (CS, CHC or IH), diameter, length and lot number. If anything is missing, ask the clinic that did the treatment to complete it.

2. A copy of the barcode

   The barcode on the product label carries the number that identifies the implant in ÜTS. Keep it with your card; if the manufacturer's warranty comes up, this is also the first piece of information you will be asked for.

3. The X-ray from day one

   The X-ray showing where your bone level was at the start. Only with it can bone loss be measured when it is compared with an X-ray taken years later.

4. The type of top part

   Whether it is the manufacturer's own part, a compatible one or custom-made for the patient. With this information, finding the right spare when a screw or top part is replaced goes faster.

Envista positions Alpha-Bio in the value segment; but the name of the implant alone does not determine the difference in a quote. The total is made up of these items:

Unit cost of the system

There may be a difference between a system positioned in the value segment and one in the premium segment; but in a plan with several units, this is often not the item that determines the total.

Top parts and prosthesis

Ready-made parts, custom-made parts or multi-unit prosthetic parts, together with the material and workmanship of the bridgework, make up most of the total in full-mouth plans.

Preparatory procedures

If a graft, a sinus procedure or extractions are needed, these are separate items, and they come up often in conventional plans. They also extend the timescale.

Scope of the warranty and repairs over the years

What the manufacturer replaces is the implant itself; labour and retreatment are discussed separately. With a system whose parts are easy to find, a repair stays a small job.