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SmartPeg Type 97 MegaGen
EUDAMEDFDA UDIClass I (EU MDR)
Ref 100743Model Single-use SmartPeg
by Osstell AB
Identity
- Trade Name
- SmartPeg Type 97 MegaGen EUDAMEDOsstell SmartPeg Type 97 FDA UDI
- Generic Name
- Dental implant stability resonance frequency analysis peg FDA UDI
- Device Name
- SmartPeg EUDAMEDISQ Measurement Peg FDA UDI
- Model / Reference
- Single-use SmartPeg EUDAMED100743 EUDAMEDOsstell SmartPeg Type 97 FDA UDI
- Description
- ISQ Measurement Peg FDA UDI
Identifiers
- Catalog Number
- 100743 FDA UDI
- Primary DI / UDI-DI
- 09010522002018 EUDAMEDFDA UDI
- Basic UDI-DI
- 9010522SmartPegsBP EUDAMED
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental implant stability resonance frequency analysis peg FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
SmartPeg Type 97 MegaGen by Osstell AB — 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 | 9010522SmartPegsBP | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Osstell AB
- EUDAMED SRN
- SE-MF-000002162
Sources (2)
- EUDAMED 39d6ab8f-6b14-457d-9fb5-995330ab0ce0 61 fields · synced Jul 11, 2026
- FDA UDI a8a43f96-118c-4d8f-9dfd-0bc0b7cc7b61 34 fields · synced May 30, 2026