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Gracey 13/14
EUDAMEDFDA UDIClass I (EU MDR)
Ref 213-214XSIModel Dental hand instrument, curette for the removal of the supragingival calculus
Identity
- Trade Name
- Gracey 13/14 EUDAMEDLMDental FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Periodontal hand instrument EUDAMEDGracey 13/14, Curette, Periodontics FDA UDI
- Model / Reference
- 213-214XSI EUDAMEDFDA UDIDental hand instrument, curette for the removal of the supragingival calculus EUDAMED
- Description
- Gracey 13/14, Curette, Periodontics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311208640 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311PERIO1r06S EUDAMEDB-06438311208640 EUDAMED
- Direct Marketing DI
- 06438311208640 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- L159001 DENTAL AND PERIODONTAL CURETTES, REUSABLE EUDAMED
- GMDN Term
- Periodontal curette 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
Gracey 13/14 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 b6a6157a-2534-4917-86a6-ea7c1761dcd7 61 fields · synced Jul 9, 2026
- EUDAMED a18a094d-effb-4dd4-99a1-c3725a4ba220 61 fields · synced May 19, 2026
- FDA UDI d843ab63-4c66-4e38-be37-ef9933afda11 33 fields · synced May 30, 2026