510(k) · Cleared
Recalled · Class II · 2025T2
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 Sep 21, 2021 as substantially equivalent to K183475 (Osstem Implant Co., Ltd., 2019) after a 60-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 21, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- OAS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K973642 (1997). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 5 generations between
- 3 generations backK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- 2 generations backK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- 1 generation backK183475 T1-CS, T1-COsstem Implant Co., Ltd. · 2019 · Recalled
- This deviceK212303 T2Osstem Implant Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK233806 T2 PlusOsstem Implant Co., Ltd. · 2024 · Recalled
Show all 9 generations
- Root · 9 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 8 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 7 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 6 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 5 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 4 generations backK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
- 3 generations backK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- 2 generations backK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- 1 generation backK183475 T1-CS, T1-COsstem Implant Co., Ltd. · 2019 · Recalled
- This deviceK212303 T2Osstem Implant Co., Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K233806T2 PlusOsstem Implant Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −8 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −7 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −6 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −5 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −4 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
| −3 | K122606 | PHT-6500; PHT-60CFO; Pax-I3D | Mtechgroup | 2012 | — |
| −2 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | 2015 | — |
| −1 | K183475 | T1-CS, T1-C | Osstem Implant Co., Ltd. | 2019 | 1 |
| 0 (this device) | K212303 | T2 | Osstem Implant Co., Ltd. | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K183475 | T1-CS, T1-CSummary page 4…: Class II - Classification Product Code : OAS 3. Predicated Device - Primary Predicate T1-CS, T1-C, Osstem Implant Co., Ltd. (K183475) 4. Description - T2 is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233806 | T2 Plus | 2024 | 0 |
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-0314-2026 | 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 24 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K233806 (Osstem Implant Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
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. 2021, 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?
T2 is digital X-Ray imaging equipment for dental professionals that convert X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (Pano), Cephalometric (Ceph), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212303 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212303: T2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212303
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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