Identity
- Trade Name
- ZrGEN Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- ZrGEN Abutment EUDAMED
- Model / Reference
- ARZXL6016L EUDAMEDARZXL6016 FDA UDI
Identifiers
- Catalog Number
- ARZXL6016L FDA UDI
- Primary DI / UDI-DI
- 08806388264438 EUDAMEDFDA UDI
- Basic UDI-DI
- 880972899104PR EUDAMED
- 510(k) Number
- K233450 FDA UDI
- FDA Product Code
- NHA FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, permanent, preformed
ZrGEN Abutment 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 Dental implant suprastructure, permanent, preformed.
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Cleared under the same submission
K233450 also covers:
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- AXA Abutment — Megagen Implant Co. Ltd
- Crown Screw — 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 |
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Manufacturer
- Manufacturer
- Megagen Implant Co. Ltd
Sources (2)
- FDA UDI fb05cb61-3b05-449e-be5a-ec9854c4e51d 34 fields · synced Oct 7, 2026
- EUDAMED 7f6295bd-8016-4fe8-b761-05b245c93d73 61 fields · synced Oct 7, 2026