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Jota
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 500205408298018Model Rotary Instruments
by Jota AG
Identity
- Trade Name
- JOTA FDA UDI
- Generic Name
- Dental polishing brush FDA UDI
- Device Name
- Carbide FDA UDI
- Model / Reference
- Rotary Instruments EUDAMED500205408298018 EUDAMEDCX161R.RAL.018 FDA UDI
- Description
- Carbide FDA UDI
Identifiers
- Primary DI / UDI-DI
- EJOT500205408298018 EUDAMEDFDA UDI
- Basic UDI-DI
- B-EJOT500205408298018 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Dental polishing brush FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4130 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
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Also classified as Dental polishing brush.
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- 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 a2b4aeb0-e107-4b52-a450-4bdcd64ad861 33 fields · synced Jul 8, 2026
- EUDAMED 3b6541b8-c574-4ab5-8355-5fe580d8bada 61 fields · synced Jul 8, 2026