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SharpJack SD
EUDAMEDFDA UDIClass I (EU MDR)
Ref 315-316SDESModel Dental hand instrument, sickle scaler for the removal of the supragingival calculus
Identity
- Trade Name
- SharpJack SD EUDAMEDLMDental FDA UDI
- Generic Name
- Manual dental scaler, reusable FDA UDI
- Device Name
- Periodontal hand instrument EUDAMEDSharpJack SD, Scaler, Periodontics FDA UDI
- Model / Reference
- Dental hand instrument, sickle scaler for the removal of the supragingival calculus EUDAMED315-316SDES EUDAMEDFDA UDI
- Description
- SharpJack SD, Scaler, Periodontics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311213088 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438311213088 EUDAMED6438311PERIO1r06S EUDAMED
- Direct Marketing DI
- 06438311213088 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 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-06438311213088 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438311213088 | 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 f5c33975-1a30-435e-a067-e920b0cc3750 61 fields · synced Jun 19, 2026
- EUDAMED a29fb35f-8774-4ad1-b6ad-806fe7245579 61 fields · synced May 18, 2026
- FDA UDI 2f6a78e2-0db0-432e-91e7-204f90ba1ba9 33 fields · synced May 27, 2026