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DIATECH Diamonds
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 60032186Model DIATECH Diamond Instruments
by Dent4You AG
Identity
- Trade Name
- DIATECH Turbocut Diamonds EUDAMEDDIATECH Diamonds FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- DIATECH TurboCut Diamonds, G848T Flat End Taper 016-10.0-C, FG, 5pcs FDA UDI
- Model / Reference
- 60032186 EUDAMEDFDA UDIDIATECH Diamond Instruments EUDAMED
- Description
- DIATECH TurboCut Diamonds, G848T Flat End Taper 016-10.0-C, FG, 5pcs FDA UDI
Identifiers
- Catalog Number
- 60032186 FDA UDI
- Primary DI / UDI-DI
- 07630243616558 EUDAMEDFDA UDI
- Basic UDI-DI
- 76303929ROTA20011CP EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Diamond dental bur, reusable
DIATECH Diamonds by Dent4You AG — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Diamond dental bur, reusable.
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- 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
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dent4You AG
Sources (2)
- FDA UDI f9429813-6f10-45da-908d-2bd385feb6d9 35 fields · synced Jul 8, 2026
- EUDAMED 7fb0799a-f1c2-4591-be33-6d5f386f47e8 61 fields · synced Jul 8, 2026