Osstem Implant Co.,Ltd. (manufacturer, Yeonsu-gu Incheon, KR): 11 new FDA device listings, incl. chair, dental, with operative unit
Osstem Implant Co.,Ltd. (Yeonsu-gu Incheon): 11 new FDA device listings, incl. chair, dental, with operative unit. Its amount of 11 is top-decile (94th percentile of 2,570 records). Dated 176 days ago, it serves as a historical benchmark. Score 75/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 11 · 94th percentile of 2,570 DeviceEstablishmentPulse records · 11.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 116 related KR DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Osstem Implant Co.,Ltd. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Foreign Private Label Distributor; Export Device to the United States But Perform No Other Operation on Device |
| Location | Yeonsu-gu Incheon, KR |
| New listings | 11 |
| Devices | Chair, Dental, With Operative Unit; Unit, Operative Dental; Unit, X-Ray, Intraoral; Chair, Dental, Without Operative Unit; X-Ray, Tomography, Computed, Dental; Unit, X-Ray, Extraoral With Timer |
| Product codes | KLC, EIA, EAP, NRU, OAS, EHD |
| Device classes | Class I, Class II |
| Medical specialties | Dental, Radiology |
| Brand names | K5; S2 (digital intra-oral X-ray sensor); K3-Chair only; K5 Cart, K5 Mount, K5 Swing; T1 C, T1-CS; N1; T2 Plus (T2-C-P, T2-CS-P); T2 (T2-C, T2-CS) |
| First new listing | 2026-05-13 |
| Latest new listing | 2026-05-13 |
| FDA registration number | 3045816948 |
| Registration expires | 2026-12-31 |
| amount percentile | 94th of 2,570 (median 1, 11.0x median) |
| Peer records CSV (117 KR records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-05-13
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Osstem Implant Co.,Ltd. and 117 KR peers
- KR DeviceEstablishmentPulse records like this one: 117
- Osstem Implant Co.,Ltd.'s amount: 94th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every KR peer: $23,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
75 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
What is the DeviceEstablishmentPulse record for Osstem Implant Co.,Ltd. in Yeonsu-gu Incheon?
Osstem Implant Co.,Ltd. (Yeonsu-gu Incheon, KR), a manufacturer, added 11 FDA device listings on 2026-05-13.
How does Osstem Implant Co.,Ltd. compare to other DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 11 is 11.0x the median of 1 across 2,570 records. It is 176 days old; check the official source for later updates before acting. Its Score of 75/100 puts it among the stronger signals in this feed.
Osstem Implant Co.,Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Osstem Implant Co.,Ltd. | Yeonsu-gu Incheon, KR | 11 | 94th | 2026-05-13 |
| Boston Scientific Corporation | Coventry, RI | 10 | 93rd | 2026-10-16 |
| Paragon 28 | Englewood, CO | 9 | 92nd | 2026-10-08 |
| Surgentec LLC | Boca Raton, FL | 15 | 96th | 2026-10-16 |
Related records
DeviceEstablishmentPulse: Manufacturer DeviceEstablishmentPulse: Foreign establishment
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.