Osstem dental implants

Osstem implants are filed with regulators under the name Osstem Implant Co., Ltd.. The company is headquartered in South Korea.

The address on its regulatory filings is: US correspondent address on K121995: Fairless Hills, PA, US.

Headquarters and factory are not always in the same place. We only list manufacturing sites after we have confirmed them, so a “made in” claim should be checked against the implant's packaging or passport.

Yes. The FDA database lists 28 endosseous implant 510(k) clearances for Osstem, the first in 2005.

Recent examples: TS Implant System (K121585, 2013); TS Fixture System (K121995, 2012).

FDA clearance means the FDA found the device substantially equivalent to one already legally sold. It is not a quality ranking and says nothing about how one brand compares with another.

Our search of the FDA recall database for the Osstem systems we cover found no recall records.

No result is not proof that no recall exists in any country. We search system by system and date every search.

The Osstem systems we cover are made of commercially pure titanium.

Osstem TSIII: Commercially pure titanium, grade 4.

Well-known Osstem implant lines include TSIII, TSIV, SS and US.

Covered in detail on this site: Osstem TSIII.

Still being researched: TSIV, SS, US and MS.

A connecting part called an abutment is screwed into the implant, and the crown, bridge or denture is fixed to it. Abutments have to match the implant's connection.

Osstem TSIII: Internal hex.

Ask your clinic which company made your abutment and crown, and write it in your implant passport. Replacement parts are easier to find when the system is known.

Ask the clinic that placed it for the implant sticker or implant passport. It shows the system, diameter, length and lot number. Keep a copy.

Implants sold in the United States carry a Unique Device Identifier (UDI). With the UDI you can look up the product in the FDA's AccessGUDID database.

If no records exist, a dentist can often narrow it down from an X-ray, but that identification is not certain.

Osstem is usually offered as a mid-range option in clinics. It is typically priced below the Swiss premium brands.

We don't publish prices, because the implant is only one part of the bill. The clinic, country, number of implants, abutment, crown, scans and any bone grafting all change the total. Ask for a quote that names the brand and system and lists everything included.

Osstem is large Korean manufacturer, common in clinics worldwide. The FDA database lists 28 implant clearances for it, the first in 2005.

No brand is best for everyone. Whether Osstem is a good choice for you depends on your bone and treatment plan, your dentist's experience with the system, and whether parts will be available where you live.

We don't publish a single survival percentage for any brand. Studies differ in patients, follow-up time and how they define success, so their numbers can't be fairly compared between brands.

What makes the biggest difference over the years is gum health, smoking, a history of gum disease, and regular professional cleaning. The European Federation of Periodontology's clinical guideline on peri-implant disease focuses on exactly these factors.