Identity
- Trade Name
- Healing Abutment FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- AnyOne Internal & ST Implant System (M6) M/ M7/ L10/ H=7/ Non-Hex FDA UDI
- Model / Reference
- AOHM70107N FDA UDI
- Description
- AnyOne Internal & ST Implant System (M6) M/ M7/ L10/ H=7/ Non-Hex FDA UDI
Identifiers
- Catalog Number
- AOHM70107NT FDA UDI
- Primary DI / UDI-DI
- 08806388287628 FDA UDI
- 510(k) Number
- K210826 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Healing 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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- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
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- Neoss Implant System — Neoss, Ltd. · Class II
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Cleared under the same submission
K210826 also covers:
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing Abutment — Megagen Implant Co. Ltd
- Healing 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 549ab8a6-f412-4f75-acda-8f21b0189fb4 35 fields · synced May 30, 2026