Identity
- Trade Name
- M4612 FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Model / Reference
- Magic Motion FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800039307079 FDA UDI
- 510(k) Number
- K162099 FDA UDI
- FDA Product Code
- NHA FDA UDIDZE FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI872.3640 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
No
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: Screw endosteal dental implant, two-pieceDental implant systemScrew endosteal dental implant, one-piece
M4612 by InnoBioSurg Co., Ltd(IBS implant Co., Ltd) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, one-piece.
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Cleared under the same submission
K162099 also covers:
- HISC00 — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- M4112 — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- M4208 — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- M4212 — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- M4308 — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- M4408 — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic FC II — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic FC II — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic FC II — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic FC II — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic FC II — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic FC II — InnoBioSurg Co., Ltd(IBS 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
- InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
Sources (1)
- FDA UDI bdbde30b-e42b-477f-a45c-520f7f713356 33 fields · synced Jun 1, 2026