Identity
- Trade Name
- Strauss & Co - Industrial Diamonds Ltd EUDAMEDdental diamond bur FDA UDI
- Generic Name
- Diamond dental bur, reusable FDA UDI
- Device Name
- Diamond Dental Bur EUDAMEDDental Diamond Bur KIT FDA UDI
- Model / Reference
- GRKIT1 EUDAMEDFDA UDI
- Description
- Dental Diamond Bur KIT FDA UDI
Identifiers
- Catalog Number
- GRKIT1 FDA UDI
- Primary DI / UDI-DI
- D877GRKIT11 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D877strauss52 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
No
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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Diamond dental bur, reusable
dental diamond bur by Strauss & Co - Industrial Diamonds Ltd — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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
- Strauss & Co - Industrial Diamonds Ltd
Sources (2)
- FDA UDI 0df5fd68-e2c1-4ab2-a47a-e63e254e61b8 34 fields · synced Oct 10, 2026
- EUDAMED 3eb00f01-64c5-458a-a1ad-fcea00e01070 61 fields · synced Oct 10, 2026