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Magic Multiunit Abutment Impression coping (Transfer type)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Magic Multiunit Abutment Impression coping (Transfer type) FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Model / Reference
- MATICN45 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800039399319 FDA UDI
- 510(k) Number
- K192197 FDA UDI
- FDA Product Code
- NHA FDA UDIDZE FDA UDI
- GMDN Term
- Dental implant system 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
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 system
Magic Multiunit Abutment Impression coping (Transfer type) by InnoBioSurg Co., Ltd(IBS implant Co., Ltd) — Class II — FDA UDI — listed in FDA GUDID
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 391127eb-f597-4f00-be6e-c11ffd514ea5 33 fields · synced May 31, 2026