Identity
- Trade Name
- ZrGEN Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Device Name
- Ø4/ C=4/ P=6/ Regular FDA UDI
- Model / Reference
- OSGSPA4046 FDA UDI
- Description
- Ø4/ C=4/ P=6/ Regular FDA UDI
Identifiers
- Catalog Number
- OSGSPA4046T FDA UDI
- Primary DI / UDI-DI
- 08809708751830 FDA UDI
- 510(k) Number
- K242030 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, permanent, preformed FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental implant suprastructure, permanent, preformed
ZrGEN Abutment by Megagen Implant Co. Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K242030 also covers:
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- EZ Post Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Octa Abutment — Megagen Implant Co. Ltd
- Octa Abutment — Megagen Implant Co. Ltd
- Octa Abutment — Megagen Implant Co. Ltd
- Octa Abutment — Megagen Implant Co. Ltd
- ZrGEN Abutment — Megagen Implant Co. Ltd
- ZrGEN Abutment — Megagen Implant Co. Ltd
- ZrGEN Abutment — 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 7fc49f98-1fcf-467c-a30e-1b55e2b56224 35 fields · synced May 31, 2026