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AnyOne Onestage Fixture
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref OSF4513LHRef OSF4513LDHRef OSF4511LDH
Identity
- Trade Name
- AnyOne Onestage Fixture FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- AnyOne Onestage Fixture EUDAMEDØ4/ L=13/ C=1.8 FDA UDIØ4.5/ L=13/ C=2.2 FDA UDIØ4.5/ L=11.5/ C=2.2 FDA UDI
- Model / Reference
- OSF4513LH EUDAMEDOSF4513LDH EUDAMEDOSF4511LDH EUDAMEDOSF4013 FDA UDIOSF4513L FDA UDIOSF4511LD FDA UDIOSF4513LD FDA UDI
- Description
- Ø4/ L=13/ C=1.8 FDA UDIØ4.5/ L=13/ C=2.2 FDA UDIØ4.5/ L=11.5/ C=2.2 FDA UDI
Identifiers
- Catalog Number
- OSF4013H FDA UDIOSF4513LH FDA UDIOSF4511LDH FDA UDIOSF4513LDH FDA UDI
- Primary DI / UDI-DI
- 08806388247080 EUDAMEDFDA UDI08806388247196 EUDAMEDFDA UDI08806388247202 EUDAMEDFDA UDI08806388246663 FDA UDI
- Basic UDI-DI
- 880972899209Q8 EUDAMED
- 510(k) Number
- K210161 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
AnyOne Onestage Fixture by Megagen Implant Co. Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — 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
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · Class II
Cleared under the same submission
K210161 also covers:
- Abutment Screw — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage Fixture — Megagen Implant Co. Ltd
- AnyOne Onestage 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Megagen Implant Co. Ltd
Sources (7)
- FDA UDI ec8dd8df-d139-4f2c-ab67-f3b54768273a 35 fields · synced Sep 17, 2026
- FDA UDI 380afdcb-21ad-4cd2-a353-2533649f397c 35 fields · synced May 29, 2026
- FDA UDI 557856ac-449c-4878-8d16-c422b0c17db3 35 fields · synced May 30, 2026
- FDA UDI 6b4a00a9-e05c-4550-ad06-a4bb4dde0727 35 fields · synced May 30, 2026
- EUDAMED d4994ce5-32dc-4bf7-b2e0-fa702a0e07df 61 fields · synced Jul 8, 2026
- EUDAMED d27cb2f3-b4c9-4b00-ac99-66576504f8d1 61 fields · synced Jul 8, 2026
- EUDAMED 1fa54415-9b07-40f7-b117-1e711f458907 61 fields · synced Jul 8, 2026