Identity
- Trade Name
- Kenson EUDAMEDFDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- Preformed Artificial Teeth EUDAMEDAnterior shade B1, mould 28, U FDA UDI
- Model / Reference
- T10B1U0028 EUDAMEDFDA UDI
- Description
- Anterior shade B1, mould 28, U FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842326113565 EUDAMEDFDA UDI
- Basic UDI-DI
- 08423261TeethXK EUDAMED
- 510(k) Number
- K924526 FDA UDI
- FDA Product Code
- ELM FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Category: Resin artificial teeth
Kenson by The Myerson Company Limited — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K924526 also covers:
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
- Kenson — The Myerson Company Limited
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- The Myerson Company Limited
Sources (2)
- FDA UDI c10d776f-3496-4b5a-849b-9505e8706d31 35 fields · synced Oct 8, 2026
- EUDAMED a3a58af9-7ec2-4d2d-82a6-3b0acec276df 61 fields · synced Oct 8, 2026