Osstem Implant Co., Ltd. (specification developer, Gangseo-gu Seoul, KR): 2 new FDA device listings, incl. unit, operative dental
Osstem Implant Co., Ltd. (Gangseo-gu Seoul): 2 new FDA device listings, incl. unit, operative dental. Its amount of 2 is above the median of 1 (69th percentile). Dated 51 days ago, it serves as a historical benchmark. Score 45/100. 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: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x 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 | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Gangseo-gu Seoul, KR |
| New listings | 2 |
| Devices | Unit, Operative Dental; Chair, Dental, With Operative Unit |
| Product codes | EIA, KLC |
| Device classes | Class I |
| Medical specialties | Dental |
| Brand names | K5 Cart, K5 Mount, K5 Swing |
| First new listing | 2026-09-14 |
| Latest new listing | 2026-09-14 |
| FDA registration number | 3031886796 |
| Registration expires | 2026-12-31 |
| amount percentile | 69th of 2,570 (median 1, 2.0x 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: 2026-09-14
- 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: 69th 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)
45 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
What is the DeviceEstablishmentPulse record for Osstem Implant Co., Ltd. in Gangseo-gu Seoul?
Osstem Implant Co., Ltd. (Gangseo-gu Seoul, KR), a specification developer (outsources manufacturing), added 2 FDA device listings on 2026-09-14.
How does Osstem Implant Co., Ltd. compare to other DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 51 days old; check the official source for later updates before acting.
Osstem Implant Co., Ltd. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Osstem Implant Co., Ltd. | Gangseo-gu Seoul, KR | 2 | 69th | 2026-09-14 |
| Davol Inc., Sub. C.R. Bard, Inc. | Warwick, RI | 3 | 77th | 2026-10-14 |
| Ge Medical Systems, LLC | Waukesha, WI | 3 | 77th | 2026-10-06 |
| Align Technology, Inc. | San Jose, CA | 3 | 77th | 2026-09-30 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) 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.