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6 Kodex Twist Drills Regular Gold, Depth-Limiting
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref K96
Identity
- Trade Name
- 6 Kodex Twist Drills Regular Gold, Depth-Limiting EUDAMEDKodex FDA UDI
- Generic Name
- Pin/post dental drill bit FDA UDI
- Device Name
- Kodex Drills EUDAMEDKodex Drill FDA UDI
- Model / Reference
- K96 EUDAMEDFDA UDI
- Description
- Kodex Drill FDA UDI
Identifiers
- Primary DI / UDI-DI
- D661K961 EUDAMEDFDA UDI
- Basic UDI-DI
- B-D661K961 EUDAMED
- FDA Product Code
- DZA FDA UDI
- EMDN Code
- Q010199 CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER EUDAMED
- GMDN Term
- Pin/post dental drill bit 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
6 Kodex Twist Drills Regular Gold, Depth-Limiting by Coltene/Whaledent Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
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-D661K961 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Coltene/Whaledent Inc.
- EUDAMED SRN
- US-MF-000015761
- Authorised Representative
- Coltène/Whaledent GmbH + Co. KG DE-AR-000005719
Sources (2)
- EUDAMED 9f4da6f3-cfed-4cfd-aa2d-7c2d82c3a6b5 61 fields · synced Jun 17, 2026
- FDA UDI 88aefde1-1332-423e-94e9-aeb2c941b058 33 fields · synced May 30, 2026