Implant system · Osstem
Osstem TSIII
Partially verifiedLast verified 27 Sept 2026 · data version 1
Quick answer
Osstem TSIII is a dental implant system from Osstem (Osstem Implant Co., Ltd.). It is made of commercially pure titanium, grade 4 with a SA (sandblasted and acid-etched) surface and uses a internal hex connection. We link 2 FDA 510(k) records to this system. Open any value below to see its source.
Manufacturer
- Brand
- Osstem
- Manufacturer (regulatory name)
- Osstem Implant Co., Ltd.
- Headquarters country
- South Korea (headquarters, not necessarily the place of manufacture)
- Status
- Currently marketed
- Also known as
- TS III, TSIII SA, TS3, Osstem TS III
Implant type
| Implant levelWhere the top of the implant sits: level with the bone, or higher up in the gum. | Submerged (bone-level) fixture Regulatory record1 source · verified 27 Sept 2026 |
|---|---|
| Body shapeThe overall shape of the screw that goes into the jaw. | Tapered body, self-tapping Regulatory record2 sources · verified 27 Sept 2026 |
Material & surface
| MaterialWhat the implant screw itself is made of. | Commercially pure titanium, grade 4 Regulatory record2 sources · verified 27 Sept 2026 |
|---|---|
| Material grade | Grade 4 (ASTM F67 cited for the ultra-wide fixture) Regulatory record1 source · verified 27 Sept 2026 |
| SurfaceHow the outer surface is treated so bone can grow onto it. | SA (sandblasted and acid-etched) Other TSIII surface variants (e.g. CA, SOI) exist in some markets — research pending. Regulatory record2 sources · verified 27 Sept 2026 |
Connection
| ConnectionHow the visible tooth part (abutment) attaches to the implant. | Internal hex Osstem describes a tapered (Morse-type) internal hex; taper angle not yet confirmed from an Osstem primary document. Regulatory record2 sources · verified 27 Sept 2026 |
|---|---|
| Connection angle | Not verified |
| Anti-rotation index | Not verified |
| Prosthetic platforms | Not verified |
Size range
| DiametersHow thick the implant is. Your dentist chooses based on your bone. | Range Ø3.5–6.8 mm across TS fixtures in the 2012 FDA summary (measured values; nominal catalogue diameters pending) Regulatory record1 source · verified 27 Sept 2026 |
|---|---|
| LengthsHow long the implant is. Shorter ones are used where there is less bone. | 7.0–15.0 mm (2012 FDA summary) Regulatory record1 source · verified 27 Sept 2026 |
Macrogeometry · technical detail for dentists
| Thread design | Not verified |
|---|---|
| Apex | Not verified |
| Neck / collar | Not verified |
Indications
| Immediate function (labeling)Whether a temporary tooth may be fitted on the same day, according to official labeling. What the regulatory labeling permits. It is not evidence that immediate loading works better with this system. | Not verified |
|---|---|
| Restrictions & cautions | Not verified |
Surgical protocol · technical detail for dentists
| Max insertion torque | Not verified |
|---|
Regulatory records
| Record | Device name (as filed) | Applicant | Decision | Date |
|---|---|---|---|---|
| K121995 | TS Fixture System | Osstem Implant Co., Ltd. | Substantially Equivalent | 29 Nov 2012 |
| K121585 | TS Implant System | Osstem Implant Co., Ltd. | Substantially Equivalent | 7 Jan 2013 |
FDA clearance means the FDA found the device substantially equivalent to a legally marketed device. It is not a ranking of quality or clinical results. EU (EUDAMED) records will be added.
Safety notices & recalls
No FDA recall record found.
openFDA recall search “product_description:TSIII” run on 27 Sept 2026: 0 result(s). No result is not proof that no recall or field safety notice exists in any market.
Clinical evidence
We have not yet linked any system-specific studies to Osstem TSIII. Evidence on materials, connections and loading protocols that applies across systems is in the evidence explorer. We don't quote single-study survival rates as brand scores.
Compare TSIII with…
Sources
- FDA 510(k) K121995 — TS Fixture System (Osstem) (510(k) summary) — U.S. Food and Drug Administration, 2012-11-29. Accessed 27 Sept 2026.
- FDA 510(k) K121585 — TS Implant System (Osstem) (510(k) summary) — U.S. Food and Drug Administration, 2013-01-07. Accessed 27 Sept 2026.
- openFDA Device 510(k) API — U.S. Food and Drug Administration. Accessed 27 Sept 2026.
OSSTEM and TSIII are trademarks of Osstem Implant Co., Ltd. Found an error? Email info@dentalimplantbrands.com.
Educational information only. Implant-system selection requires assessment by a qualified dental professional.