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Twist Step Drill 4.2/4.6 10-18mm

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 34583

by Nobel Biocare AB

Identity

Trade Name
Twist Step Drill 4.2/4.6 10-18mm EUDAMED
Nobel Biocare® FDA UDI
Generic Name
Fluted surgical drill bit, single-use FDA UDI
Device Name
Drills for osteotomy EUDAMED
Twist Step Drill 4.2/4.6 10-18mm FDA UDI
Model / Reference
34583 EUDAMEDFDA UDI
Description
Twist Step Drill 4.2/4.6 10-18mm FDA UDI

Identifiers

Catalog Number
34583 FDA UDI
Primary DI / UDI-DI
07332747190045 EUDAMEDFDA UDI
Basic UDI-DI
73327470000001206M EUDAMED
FDA Product Code
NDP FDA UDI
EMDN Code
Q010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
GMDN Term
Fluted surgical drill bit, single-use FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class 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 — 18.000 Millimeter FDA UDI
Outer Diameter — 4.600 Millimeter FDA UDI

Twist Step Drill 4.2/4.6 10-18mm 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

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Manufacturer

Manufacturer
Nobel Biocare AB
EUDAMED SRN
SE-MF-000000009

Sources (2)

  • EUDAMED dbd513b5-4dae-4a39-b0b2-6766c637d835 61 fields · synced Jun 18, 2026
  • FDA UDI 9b8c67e4-68a4-4a66-8b52-a0e95e47cec9 37 fields · synced May 30, 2026