Data / Medical devices / South Korea / Seilglobal Co., Ltd
Seilglobal Co., Ltd: FDA-registered device maker in Busan Gyeongnam, South Korea, 1 510(k) clearance
Seilglobal Co., Ltd is registered with the FDA (registration 3007353764) in Busan Gyeongnam, South Korea. It lists 10 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 23, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007353764
- Address
- 191, Gaejwa-ro Geumjeong-gu, Busan Gyeongnam, South Korea, 609-845
- Owner or operator
- Seilglobal CO., Ltd (10045865)
- Roles
- Manufacturer
- First device listed
- January 7, 2014
- Registered through
- 2026
- Brand names listed
- ADD POP BOW, Autoclavable Irrigation Tube, Cartridge 50m, Composite Syringe, DentiAnn Imp Save Syringe, DentiAnn Impression Saver, DentiAnn Smart Sil, Disposable Impression Tray and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown, Preformed | ELZ | 1 | Manufacturer | accessdata.fda.gov |
| Facebow | KCR | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Manufacturer | accessdata.fda.gov |
| Tip, Rubber, Oral Hygiene | JEW | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Manufacturer | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 23, 2015 | K143382 | DentiAnn Smart Sil | ELW | Substantially Equivalent | Seilglobal Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Material, Impression Tray, Resin
- All makers of Unit, Oral Irrigation
- All makers of Mirror, Mouth
- All makers of Material, Impression
- All makers of Facebow
- All makers of Zinc Oxide Eugenol
Updated February 23, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.