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Jota
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 658204030523090Model Rotary Instruments
by Jota AG
Identity
- Trade Name
- JOTA FDA UDI
- Generic Name
- Dental polishing brush FDA UDI
- Device Name
- Polishers FDA UDI
- Model / Reference
- Rotary Instruments EUDAMED658204030523090 EUDAMED9115M.RA.090 FDA UDI
- Description
- Polishers FDA UDI
Identifiers
- Primary DI / UDI-DI
- EJOT658204030523090 EUDAMEDFDA UDI
- Basic UDI-DI
- B-EJOT658204030523090 EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental polishing brush FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6010 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 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental polishing brush
Jota by Jota AG — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental polishing brush.
- Orthoquest — Young Innovations, Inc. · Class I
- Polishers — DFS - DIAMON GmbH · Class I
- Polishers — DFS - DIAMON GmbH · Class I
- Polishers — DFS - DIAMON GmbH · Class I
- Polishers — DFS - DIAMON GmbH · Class I
- Polishers — DFS - DIAMON GmbH · Class I
- Polishers — DFS - DIAMON GmbH · Class I
- Polishers — DFS - DIAMON GmbH · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Jota AG
Sources (2)
- FDA UDI df3ddb4d-b604-4827-bc7e-09579cf21b83 33 fields · synced Jul 8, 2026
- EUDAMED ceace360-ac52-44b9-808b-cc6494c67d98 61 fields · synced Jul 8, 2026