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Horico
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AuFG199C018Model Dental diamond Burs and abrasive disks
Identity
- Trade Name
- HORICO EUDAMEDFDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- Dental diamond instruments EUDAMEDRotary diamond instrument FDA UDI
- Model / Reference
- Dental diamond Burs and abrasive disks EUDAMEDAuFG199C018 EUDAMEDAUFG198G025 FDA UDI
- Description
- Rotary diamond instrument FDA UDI
Identifiers
- Primary DI / UDI-DI
- +EHORAUFG199C0181 EUDAMEDEHORAUFG198G0252 FDA UDI
- Basic UDI-DI
- B-+EHORAUFG199C0181 EUDAMED
- FDA Product Code
- DZP FDA UDI
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE 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
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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: Carbide dental bur, single-use
Horico by Hopf, Ringleb & Co. GmbH & Cie. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbide dental bur, single-use.
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
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- SSW CARBIDE GREAT WHITE — SS White Burs LLC · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
- DIAMOND BUR 1015C - Box with 10 — 3R Indústria E Comércio LTDA · Class I
- MDT Diamond Coated Dental Burs — MDT Micro Diamond Technologies Ltd. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-+EHORAUFG199C0181 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hopf, Ringleb & Co. GmbH & Cie.
- EUDAMED SRN
- DE-MF-000006869
Sources (2)
- EUDAMED 29f7f76e-86ae-4198-8d74-5bfb1c0cb1cf 61 fields · synced Jul 17, 2026
- FDA UDI 90593435-7c3c-442d-9dfe-08f23bbc5444 33 fields · synced May 26, 2026