Identity
- Trade Name
- Magic Abutment FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Model / Reference
- MMF2N5002 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800039389105 FDA UDI
- 510(k) Number
- K192197 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant system 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 Unsafe FDA UDI
Category: Dental implant system
Magic Abutment by InnoBioSurg Co., Ltd(IBS implant Co., Ltd) — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
- Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
- Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
- Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · Class II
- Denture Retention Attachments — IMPLANT ATTACHMENTS LLC · Class II
- Chaorum Implant System — Medimecca Co., Ltd. · Class II
- JDEvolution Plus — Jdentalcare Srl · Class II
Cleared under the same submission
K192197 also covers:
- AMII IMPLANT — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- AMII IMPLANT — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- AMII IMPLANT — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- AMII IMPLANT — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- AMII IMPLANT — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd)
- Magic Abutment — 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 8413f0c3-40ca-4280-8adc-0ae77115ec71 33 fields · synced May 30, 2026