Identity
- Trade Name
- XPEED AnyRidge Internal Fixture FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- XPEED AnyRidge Internal Implant System (C3.3) Ø3.5/ L7.0 FDA UDI
- Model / Reference
- AR333505 FDA UDI
- Description
- XPEED AnyRidge Internal Implant System (C3.3) Ø3.5/ L7.0 FDA UDI
Identifiers
- Catalog Number
- AR333505XAC FDA UDI
- Primary DI / UDI-DI
- 08809822766475 FDA UDI
- 510(k) Number
- K140091 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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 — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
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- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
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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
- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Megagen Implant Co. Ltd
Sources (1)
- FDA UDI 9b153b9d-9713-44f4-bebb-9daa8ed6b40c 35 fields · synced May 30, 2026