Guided Twist Step Drill Ø3.2/3.6 (10+) 7-13mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Guided Twist Step Drill Ø3.2/3.6 (10+) 7-13mm EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- Guided drills for osteotomy EUDAMEDGuided Twist Step Drill Ø3.2/3.6 (10+) 7-13mm FDA UDI
- Model / Reference
- 35841 EUDAMEDFDA UDI
- Description
- Guided Twist Step Drill Ø3.2/3.6 (10+) 7-13mm FDA UDI
Identifiers
- Catalog Number
- 35841 FDA UDI
- Primary DI / UDI-DI
- 07332747190120 EUDAMEDFDA UDI
- Basic UDI-DI
- 733274700000014473 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 13.000 Millimeter FDA UDIOuter Diameter — 3.600 Millimeter FDA UDI
Category: Carbide dental bur, single-use
Guided Twist Step Drill Ø3.2/3.6 (10+) 7-13mm by Nobel Biocare AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 733274700000014473 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 9c7d1783-71ea-43d5-983d-4fc9957b5160 61 fields · synced Jul 8, 2026
- FDA UDI 56a5e868-b794-493b-a37e-f3e4e5caf5f1 37 fields · synced May 27, 2026