Identity
- Trade Name
- ST Internal Fixture FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- ST Internal Fixture EUDAMEDØ3.5/ L=15 FDA UDI
- Model / Reference
- ST3515C EUDAMEDST3515 FDA UDI
- Description
- Ø3.5/ L=15 FDA UDI
Identifiers
- Catalog Number
- ST3515C FDA UDI
- Primary DI / UDI-DI
- 08806388236770 EUDAMEDFDA UDI
- Basic UDI-DI
- 880972899133PY EUDAMED
- 510(k) Number
- K192347 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Screw endosteal dental implant, two-piece
ST Internal Fixture by Megagen Implant Co. Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K192347 also covers:
- Abutment Screw — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Megagen Implant Co. Ltd
Sources (2)
- FDA UDI 8ff0ddd7-1c17-41ae-a07e-d2e1d8450012 35 fields · synced Oct 9, 2026
- EUDAMED eeb984ad-391f-4b08-bcf0-7b6a95afcca4 61 fields · synced Oct 9, 2026