510(k) · Cleared
Recalled · Class II · 2025T1-CS, T1-C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osstem Implant Co., Ltd. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Aug 30, 2019 as substantially equivalent to K152106 (VATECH Co., Ltd., 2015) after a 256-day review. Its family tree reaches back 8 generations to 1997. 2 later devices descend from it. It has been recalled once.
- Decided
- Aug 30, 2019
- Review
- 256 days
- Class
- Class II
- Product code
- OAS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K973642 (1997). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 7 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 6 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 5 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 4 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 3 generations backK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
- 2 generations backK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- 1 generation backK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- This deviceK183475 T1-CS, T1-COsstem Implant Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK212303 T2Osstem Implant Co., Ltd. · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK233806 T2 PlusOsstem Implant Co., Ltd. · 2024 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −7 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −6 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −5 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −4 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −3 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
| −2 | K122606 | PHT-6500; PHT-60CFO; Pax-I3D | Mtechgroup | 2012 | — |
| −1 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | 2015 | — |
| 0 (this device) | K183475 | T1-CS, T1-C | Osstem Implant Co., Ltd. | 2019 | — |
| +1 | K212303 | T2 | Osstem Implant Co., Ltd. | 2021 | 1 |
| +2 | K233806 | T2 Plus | Osstem Implant Co., Ltd. | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OAS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OAS device
- #1 K213226 RCT700score 18.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartSummary page 5…me: PHT-30LFO (Pax-i3D Smart) Regulation Name: Computed Tomography X-ray System Classification No.: 21CFR 892.1750, Class II Product Code: OAS 510(k) Number: K152106 9. Substantial Equivalence: “T1-CS, T1-C” described in this 510(k) has the similar intended use and technical characteristics as… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212303 | T2 | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2025 | Class II | Z-0313-2026 | Radiation Control for Health and Safety Act | Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K212303 (Osstem Implant Co., Ltd., 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K152106.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
T1-C, T1-CS are a computed tomography x-ray system intended to produce panoramic, cephalometric or crosssectional images of the oral anatomy on a real time basis by computer reconstruction of X-ray image data from the same axial plane taken at different angles. It provides diagnostic details of the anatomic structures by acquiring 360 ° rotational image sequences of oral and maxillofacial area for a precise treatment planning in adult and pediatric dentistry. The device is operated and used by physicians, dentists, and X-ray technicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183475 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183475: T1-CS, T1-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183475
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026