← Back to catalogue
Guided Twist Step Drill Ø3.8/4.2 (10+) 7-13mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 35842
Identity
- Trade Name
- Guided Twist Step Drill Ø3.8/4.2 (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 Ø3.8/4.2 (10+) 7-13mm FDA UDI
- Model / Reference
- 35842 EUDAMEDFDA UDI
- Description
- Guided Twist Step Drill Ø3.8/4.2 (10+) 7-13mm FDA UDI
Identifiers
- Catalog Number
- 35842 FDA UDI
- Primary DI / UDI-DI
- 07332747190137 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
EUDAMEDFDA UDI
Single Use
Yes
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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 13.000 Millimeter FDA UDIOuter Diameter — 4.200 Millimeter FDA UDI
Guided Twist Step Drill Ø3.8/4.2 (10+) 7-13mm by Nobel Biocare AB — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (2)
- EUDAMED 2bc66185-9652-498e-a9e6-463c7b1b9232 61 fields · synced Jul 15, 2026
- FDA UDI daaaf7eb-5938-47e1-a11b-e9c95a109246 37 fields · synced May 29, 2026