Identity
- Trade Name
- Multi-unit Abutment Screw FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- M2/ L=6.8 FDA UDI
- Model / Reference
- MUAAOS FDA UDI
- Description
- M2/ L=6.8 FDA UDI
Identifiers
- Catalog Number
- MUAAOS FDA UDI
- Primary DI / UDI-DI
- 08806388243969 FDA UDI
- 510(k) Number
- K203808 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
Category: Dental implant suprastructure, temporary, preformed, single-use
Multi-unit Abutment Screw by Megagen Implant Co. Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K203808 also covers:
- CCM Cylinder — Megagen Implant Co. Ltd
- Cylinder Screw — Megagen Implant Co. Ltd
- Healing Cap — Megagen Implant Co. Ltd
- Multi-unit Abutment — Megagen Implant Co. Ltd
- Multi-unit Abutment — Megagen Implant Co. Ltd
- Multi-unit Abutment — Megagen Implant Co. Ltd
- Multi-unit Abutment Package — Megagen Implant Co. Ltd
- Multi-unit Abutment Package — Megagen Implant Co. Ltd
- Multi-unit Abutment Package — Megagen Implant Co. Ltd
- Multi-unit Abutment Package — Megagen Implant Co. Ltd
- Multi-unit Abutment Package — Megagen Implant Co. Ltd
- Multi-unit Abutment Package — 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 80af44f2-48c5-4ad5-b329-e7e3cf33efe3 35 fields · synced Jun 1, 2026