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Mini Kaplan
EUDAMEDFDA UDIClass I (EU MDR)
Ref 333-334XSIModel Dental hand instrument, sickle scaler for the removal of the supragingival calculus
Identity
- Trade Name
- Mini Kaplan EUDAMEDLMDental FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Periodontal hand instrument EUDAMEDMini Kaplan, Scaler, Periodontics FDA UDI
- Model / Reference
- 333-334XSI EUDAMEDFDA UDIDental hand instrument, sickle scaler for the removal of the supragingival calculus EUDAMED
- Description
- Mini Kaplan, Scaler, Periodontics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311213361 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311PERIO1r06S EUDAMEDB-06438311213361 EUDAMED
- Direct Marketing DI
- 06438311213361 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159001 DENTAL AND PERIODONTAL CURETTES, REUSABLE EUDAMED
- GMDN Term
- Manual dental scaler, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
No
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
Yes
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
Mini Kaplan by LM-Instruments Oy — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 6438311PERIO1r06S | Class I | Active |
| EUDAMED | European Union | CE/MDR | 6438311PERIO1r06S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LM-Instruments Oy
- EUDAMED SRN
- FI-MF-000006705
Sources (3)
- EUDAMED c2d8e3f6-63f9-4d33-bc76-b8d47c6fb899 61 fields · synced Jun 18, 2026
- EUDAMED bc2263ed-3122-4422-a3b9-4969c04ddad6 61 fields · synced May 19, 2026
- FDA UDI 8a519a52-6ca2-426d-ba7c-bc21a50acf3a 33 fields · synced May 30, 2026