Identity
- Trade Name
- Master Fix FDA UDI
- Generic Name
- Dental implant suprastructure, permanent, preformed FDA UDI
- Model / Reference
- NBR_M5545THP FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800265642579 FDA UDI
- 510(k) Number
- K240603 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
No
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
Master Fix by ARUM DENTISTRY 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
K240603 also covers:
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY Co., Ltd.
- Master Fix — ARUM DENTISTRY 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
- ARUM DENTISTRY Co., Ltd.
Sources (1)
- FDA UDI e0f8580c-9799-4f20-9556-0954a5c34140 33 fields · synced Jun 8, 2026