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Implant Gracey 11/12 Mini ErgoMix
EUDAMEDFDA UDIClass I (EU MDR)
Ref 211-212MTIEMModel Dental hand instrument, titanium curette for implant maintenance
Identity
- Trade Name
- Implant Gracey 11/12 Mini ErgoMix EUDAMEDLMDental FDA UDI
- Generic Name
- Periodontal curette FDA UDI
- Device Name
- Periodontal hand instrument EUDAMEDImplant Gracey 11/12 Mini ErgoMix, Curette, Periodontal FDA UDI
- Model / Reference
- Dental hand instrument, titanium curette for implant maintenance EUDAMED211-212MTIEM EUDAMEDFDA UDI
- Description
- Implant Gracey 11/12 Mini ErgoMix, Curette, Periodontal FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06438311207643 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06438311207643 EUDAMED6438311PERIO1r06S EUDAMED
- Direct Marketing DI
- 06438311207643 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
Implant Gracey 11/12 Mini ErgoMix 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-06438311207643 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-06438311207643 | 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 03b78a0c-ac56-481f-936e-54a93dbe1c61 61 fields · synced Jun 19, 2026
- EUDAMED 903efe96-cd09-4e8a-aed0-27e09bb7e557 61 fields · synced May 19, 2026
- FDA UDI 5ce7e8be-174e-4095-bb8a-b8ade0584315 33 fields · synced May 30, 2026