Tryon
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- IMP. TRYON CO HE Ø4.0X11.5MM EUDAMEDTryon FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- IMPLANT TRYON | IMPLANT STRONG SW | IMPLANT EPIKUT EUDAMEDIMPLANT TRYON Ø4,0 X 11,5mm FDA UDI
- Model / Reference
- SCOT 411 EUDAMEDFDA UDIDENTAL IMPLANTS WITHOUT HYDROXYAPATITE EUDAMED
- Description
- IMPLANT TRYON Ø4,0 X 11,5mm FDA UDI
Identifiers
- Catalog Number
- SCOT 411 FDA UDI
- Primary DI / UDI-DI
- 07899995213105 EUDAMEDFDA UDI
- Basic UDI-DI
- 999520000001JG EUDAMED
- 510(k) Number
- K193096 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, one-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Portugal 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, one-piece
Tryon by S.I.N. - Sistema DE Implante Nacional S.A. — 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, one-piece.
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Cleared under the same submission
K193096 also covers:
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
- CADCAM Abutment — S.I.N. - Sistema DE Implante Nacional S.A.
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 |
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Manufacturer
- Manufacturer
- S.I.N. - Sistema DE Implante Nacional S.A.
Sources (2)
- FDA UDI 3510d7fa-36e4-4fd2-90be-9a965d81c2e5 35 fields · synced Oct 7, 2026
- EUDAMED 85b2bb3c-1369-4f9f-b2ff-cc0095b2f6a9 61 fields · synced Oct 7, 2026