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XPEED AnyRidge Internal Fixture
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AR385511XACRef FALIHX7508XACRef FANIHX4008C
Identity
- Trade Name
- XPEED AnyRidge Internal Fixture FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- XPEED AnyRidge Internal Fixture EUDAMEDXPEED AnyRidge Internal Implant System (C3.3) Ø5.0/ L7.0 FDA UDIAnyRidge Internal Ø4/ L=8.5 FDA UDIXPEED AnyRidge Internal Implant System (C3.8) Ø5.5/ L11.5 FDA UDI
- Model / Reference
- AR385511XAC EUDAMEDFALIHX7508XAC EUDAMEDFANIHX4008C EUDAMEDAR335005 FDA UDIFANIHX4008 FDA UDIAR385511 FDA UDI
- Description
- XPEED AnyRidge Internal Implant System (C3.3) Ø5.0/ L7.0 FDA UDIAnyRidge Internal Ø4/ L=8.5 FDA UDIXPEED AnyRidge Internal Implant System (C3.8) Ø5.5/ L11.5 FDA UDI
Identifiers
- Catalog Number
- AR335005XAC FDA UDIFANIHX4008C FDA UDIAR385511XAC FDA UDI
- Primary DI / UDI-DI
- 08806388217519 EUDAMEDFDA UDI08809822766833 EUDAMEDFDA UDI08809822767267 EUDAMED08809822766444 FDA UDI
- Basic UDI-DI
- 880972899192QG EUDAMED
- 510(k) Number
- K140091 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Screw endosteal dental implant, two-piece
XPEED AnyRidge 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
K140091 also covers:
- AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- XPEED AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- XPEED AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- XPEED AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- XPEED AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- XPEED AnyRidge Internal Fixture — Megagen Implant Co. Ltd
- XPEED AnyRidge Internal Fixture — Megagen Implant Co. Ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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
- Megagen Implant Co. Ltd
Sources (6)
- FDA UDI a11c5a62-1df4-4251-92f0-552a5b02c183 35 fields · synced Sep 30, 2026
- FDA UDI 70e7f26c-b60d-40e1-8344-f0efe6740415 35 fields · synced May 29, 2026
- FDA UDI 6e7281e3-59e2-4fb2-8948-94497d6e21c7 35 fields · synced May 30, 2026
- EUDAMED 1ed46495-1e8a-42f9-9626-0fcca7de963e 61 fields · synced Jul 8, 2026
- EUDAMED ff448d11-45ad-4d30-b6bc-7f88580c06a4 61 fields · synced Jul 8, 2026
- EUDAMED bcc67306-95b4-4a88-8e1b-5dcc383d4b55 61 fields · synced Jul 8, 2026