Identity
- Trade Name
- Multi M Series FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- M2D4Z25 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800155233832 FDA UDI
- 510(k) Number
- K250826 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental appliance fabrication material, ceramic
Multi M Series by DMAX Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental appliance fabrication material, ceramic.
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Cleared under the same submission
K250826 also covers:
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX Co., Ltd.
- Multi M Series — DMAX 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
- DMAX Co., Ltd.
Sources (1)
- FDA UDI 8cab2365-8ca4-42bc-9bd2-3d4874870ff5 33 fields · synced May 30, 2026