SmartPeg Type 45
EUDAMEDFDA UDIClass I (EU MDR)
by Osstell AB
Identity
- Trade Name
- SmartPeg Type 45 EUDAMEDOsstell SmartPeg Type 45 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 EUDAMED100472 EUDAMEDOsstell SmartPeg Type 45 FDA UDI
- Description
- ISQ Measurement Peg FDA UDI
Identifiers
- Catalog Number
- 100472 FDA UDI
- Primary DI / UDI-DI
- 09010522001547 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
A medical device review directory, providing in-depth information and testing data for various devices, including the SmartPeg Type 45. This tool is designed to help users understand the features, compliance, and more about the SmartPeg Type 45.
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
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 bcf2ad46-d59a-4fb3-af43-9ef8068a4dd7 61 fields · synced Jul 9, 2026
- FDA UDI 03207ec2-c992-4557-b742-dde371f33806 34 fields · synced May 30, 2026