Guided Twist Step Drill Ø2.8/3.2 (10+) 7-18mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Guided Twist Step Drill Ø2.8/3.2 (10+) 7-18mm 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 Ø2.8/3.2 (10+) 7-18mm FDA UDI
- Model / Reference
- 35875 EUDAMEDFDA UDI
- Description
- Guided Twist Step Drill Ø2.8/3.2 (10+) 7-18mm FDA UDI
Identifiers
- Catalog Number
- 35875 FDA UDI
- Primary DI / UDI-DI
- 07332747190168 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 — 18.000 Millimeter FDA UDIOuter Diameter — 3.200 Millimeter FDA UDI
Category: Carbide dental bur, single-use
Guided Twist Step Drill Ø2.8/3.2 (10+) 7-18mm 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 9cdc10a3-7fd8-4421-bd08-f2d910761ca4 61 fields · synced Jul 14, 2026
- FDA UDI f9459577-063f-43d8-a8c2-301d17f0e5a1 37 fields · synced May 30, 2026