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Oktagon
EUDAMEDFDA UDIClass I (EU MDR)
Ref 64570Model Hand-held instruments dentistryRef 41210Model Prosthetic abutment systems
Identity
- Trade Name
- Oktagon EUDAMEDOKTAGON® FDA UDI
- Generic Name
- Manual non-rotary dental instrument handle FDA UDI
- Device Name
- Manual instrument for dental/surgical application FDA UDI
- Model / Reference
- Hand-held instruments dentistry EUDAMED64570 EUDAMEDFDA UDIProsthetic abutment systems EUDAMED41210 EUDAMED
- Description
- Manual instrument for dental/surgical application FDA UDI
Identifiers
- Catalog Number
- 64570 FDA UDI
- Primary DI / UDI-DI
- E0HM645701 EUDAMEDFDA UDIE0HM412101 EUDAMED
- Basic UDI-DI
- ++E0HM352I01AAPS EUDAMED++E0HM305IIB00AA33 EUDAMED
- FDA Product Code
- DZN FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMEDP01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Manual non-rotary dental instrument handle FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass IIb EUDAMED
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDIEUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Oktagon by Hager & Meisinger GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E0HM352I01AAPS | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hager & Meisinger GmbH
- EUDAMED SRN
- DE-MF-000004966
Sources (3)
- EUDAMED a0f198fe-223a-4110-a717-1b528d2eb007 61 fields · synced Oct 6, 2026
- FDA UDI 65b88ba6-8189-4ead-946c-f6e5715bf2df 35 fields · synced May 30, 2026
- EUDAMED 1895a434-f1aa-4781-90eb-1850e69286cc 61 fields · synced Jul 17, 2026