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Tip Implant Gracey Mini 2 ErgoMix
EUDAMEDFDA UDIClass I (EU MDR)
Ref 202MTIEMModel Tip for dental hand instrument, titanium curette for implant maintenance
Identity
- Trade Name
- Tip Implant Gracey Mini 2 ErgoMix EUDAMEDLMDental FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Periodontal hand instrument EUDAMEDTip Implant Gracey Mini 2 ErgoMix, Curette, Periodontics FDA UDI
- Model / Reference
- 202MTIEM EUDAMEDFDA UDITip for dental hand instrument, titanium curette for implant maintenance EUDAMED
- Description
- Tip Implant Gracey Mini 2 ErgoMix, Curette, Periodontics FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311206196 EUDAMEDFDA UDI
- Basic UDI-DI
- 6438311PERIO1r06S EUDAMEDB-06438311206196 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
Tip Implant Gracey Mini 2 ErgoMix 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 b1d09a13-4696-4dc9-80f5-5770de04b728 61 fields · synced Jul 16, 2026
- EUDAMED 67ea2980-57f1-4937-a928-619b077d47b0 61 fields · synced May 19, 2026
- FDA UDI 680b1083-773b-4cb5-9a51-c7b8a28c5eff 33 fields · synced May 30, 2026