Identity
- Trade Name
- Meg-Ball Package FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- MBAO70P FDA UDI
Identifiers
- Catalog Number
- MBAO70P FDA UDI
- Primary DI / UDI-DI
- 08809708750017 FDA UDI
- 510(k) Number
- K192614 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
Meg-Ball Package 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, permanent, preformed.
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Cleared under the same submission
K192614 also covers:
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Abutment — Megagen Implant Co. Ltd
- Meg-Ball Package — Megagen Implant Co. Ltd
- Meg-Ball 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 062a81ce-ea13-4920-8008-e424d9ff413c 34 fields · synced May 30, 2026