Identity
- Trade Name
- Temporary Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- EZTN400 FDA UDI
Identifiers
- Catalog Number
- EZTN400T FDA UDI
- Primary DI / UDI-DI
- 08806388216413 FDA UDI
- 510(k) Number
- K203554 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use 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, temporary, preformed, single-use
Temporary Abutment by Megagen Implant Co. Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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Cleared under the same submission
K203554 also covers:
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- Angled Abutment — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External Fixture — Megagen Implant Co. Ltd
- AnyOne External 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 d0213241-d10a-4bff-80f3-0bf19be0e535 34 fields · synced Jun 8, 2026