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SharpJack SD DTS U
EUDAMEDFDA UDIClass I (EU MDR)
Ref 315-316SDESTUModel Dental hand instrument, sickle scaler for the removal of the supragingival calculus
Identity
- Trade Name
- SharpJack SD DTS U EUDAMEDLMDental FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Periodontal hand instrument EUDAMEDSharpJack SD DTS U, Scaler, Periodontics FDA UDI
- Model / Reference
- Dental hand instrument, sickle scaler for the removal of the supragingival calculus EUDAMED315-316SDESTU EUDAMEDFDA UDI
- Description
- SharpJack SD DTS U, Scaler, Periodontics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311213101 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438311213101 EUDAMED6438311PERIO1r06S EUDAMED
- Direct Marketing DI
- 06438311213101 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
SharpJack SD DTS U by LM-Instruments Oy — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06438311213101 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438311213101 | 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 76ff7ca7-ab33-4ecb-b4ba-c618cc1f78e2 61 fields · synced Jul 19, 2026
- EUDAMED 88d527f2-2214-4322-ad67-ed245d619a60 61 fields · synced May 18, 2026
- FDA UDI c45ed87d-b206-4e89-b0fd-63141426b944 33 fields · synced May 30, 2026