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Jota
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 806314157544012Model Rotary Instruments
by Jota AG
Identity
- Trade Name
- JOTA FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- Diamonds FDA UDI
- Model / Reference
- Rotary Instruments EUDAMED806314157544012 EUDAMED841SG.FG.012 FDA UDI
- Description
- Diamonds FDA UDI
Identifiers
- Primary DI / UDI-DI
- EJOT806314157544012 EUDAMEDFDA UDI
- Basic UDI-DI
- B-EJOT806314157544012 EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Diamond dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4535 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: Diamond dental bur, reusable
Jota by Jota AG — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Diamond dental bur, reusable.
- Midwest Diamonds — Sirona Dental Systems GmbH · Class I
- Sabur by 3D Dental — 3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- MAXCUT DIAMOND BURS (6/pk) CRS 6852-012 — SCOTT'S DENTAL SUPPLY L.L.C. · Class I
- Two Striper — ABRASIVE TECHNOLOGY, LLC · Class I
- Diatech Diamond Instruments — Coltène/Whaledent AG · Class I
- HORICO — Hopf, Ringleb & Co. GmbH & Cie. · 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 53a74f26-d221-41d0-b1a1-03103bd166f4 33 fields · synced Sep 30, 2026
- EUDAMED 7a92fdb3-1ce4-4a36-ac53-a0780dcf8f59 61 fields · synced Jul 8, 2026