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On1 Clinical Screw 1.75 mm NP

Multi-unit screws

Class IIbMDR 2017/745On the marketWell-established tech (possible)ImplantableSingle useSterileSutures

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747191882
Basic UDI-DI: 73327470000001827B
Reference: 38744
EMDN: P01020180
EMDN description: DENTAL IMPLANTS - ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:11

Manufacturer products View details

On1 IOS Healing Cap 6 mm NP

IOS Healing Abutments

Class IIbMDR 2017/745On the marketWell-established tech (possible)ImplantableSingle useSterileSutures

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747191820
Basic UDI-DI: 73327470000002216U
Reference: 38734
EMDN: P01020180
EMDN description: DENTAL IMPLANTS - ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:11

Manufacturer products View details

On1 Temporary Abutment Engaging NP

Temporary prosthetic abutments

Class IIbMDR 2017/745On the marketWell-established tech (possible)ImplantableSingle useSterileSutures

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747191769
Basic UDI-DI: 733274700000017278
Reference: 38701
EMDN: P01020180
EMDN description: DENTAL IMPLANTS - ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:11

Manufacturer products View details

Trephine Drill 3.2/4.0mm

Rescue instruments

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747190649
Basic UDI-DI: 73327470000001487B
Reference: 37477
EMDN: Q010501
EMDN description: DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:11

Manufacturer products View details

Cover Screw Conical Connection NP

CC cover screws

Class IIbMDR 2017/745On the marketWell-established tech (possible)ImplantableSingle useSterileSutures

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747190380
Basic UDI-DI: 73327470000001316S
Reference: 36649
EMDN: P01020180
EMDN description: DENTAL IMPLANTS - ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:11

Manufacturer products View details

Zygoma Implant Cover Screw

Zygoma cover screws

Class IIbMDR 2017/745On the marketWell-established tech (possible)ImplantableSingle useSterileSutures

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747188608
Basic UDI-DI: 73327470000001326U
Reference: 28989
EMDN: P01020180
EMDN description: DENTAL IMPLANTS - ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:11

Manufacturer products View details

Cover Screw Brånemark System® NP

Straight & machined cover screws

Class IIbMDR 2017/745On the marketWell-established tech (possible)ImplantableSingle useSterileSutures

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747188578
Basic UDI-DI: 73327470000001336W
Reference: 28986
EMDN: P01020180
EMDN description: DENTAL IMPLANTS - ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:11

Manufacturer products View details

Guided Implant Mount NobelActive NP

Guided implant placement tools

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747187717
Basic UDI-DI: 73327470000001577C
Reference: 35887
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:11

Manufacturer products View details

IPS CaseDesigner 2.3 for Windows 64-bit

Diagnostic and treatment software

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747185829
Basic UDI-DI: 733274700000016275
Reference: 300011_V2.3_WIN64
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

Guided Drill Tapered NP 3.5x(+)8mm

Guided reusable drills for osteotomy

Class IIaMDR 2017/745On the marketDirect marking

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747185553
Basic UDI-DI: 733274700000014677
Reference: 32827
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

DTX Studio Implant 3.6 for Win 64-bit

Diagnostic and treatment software

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747181937
Basic UDI-DI: 73327470000002206S
Reference: 300843_V3.6_WIN64
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

DTX Studio Lab 1.12 for Windows 64-bit

Design software

Class IMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747180756
Basic UDI-DI: 73327470000002146X
Reference: 300607_V1.12_WIN64
EMDN: Z11069082
EMDN description: VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

Guided Anchor Pin Sleeve Ø1.5mm 3/pkg

Guided surgical template fixation

Class IMDR 2017/745On the marketSingle use

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747178722
Basic UDI-DI: 73327470000001957L
Reference: 30908
EMDN: Q010399
EMDN description: SURGICAL DENTAL DEVICES - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

Implant Retrieval Instrument CC 3.0 31mm

Retrieval instruments

Class IIaMDR 2017/745On the marketSingle useSterile

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747177367
Basic UDI-DI: 73327470000001757E
Reference: 37473
EMDN: Q010501
EMDN description: DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

Direction Indicator Nobel Biocare N1™

Direction indicators

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747176827
Basic UDI-DI: 733274700000016377
Reference: 300918
EMDN: L159003
EMDN description: DENTAL AND PERIODONTAL PROBES AND EXPLORERS, REUSABLE
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

Bone Mill Guide Nobel Biocare N1™ TCC NP Ø4.0

Bone mill guide

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747176780
Basic UDI-DI: 73327470000001567A
Reference: 300911
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

Position Locator Single Abutment Nobel Biocare On1

Lab position locators

Class IMDR 2017/745On the market

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747176421
Basic UDI-DI: 73327470000001967N
Reference: 300437
EMDN: Q010299
EMDN description: PROSTHETIC DENTISTRY DEVICES - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

Try-in Screw Trefoil™ 3/pkg

Trefoil lab tools for prosthetics

Class IMDR 2017/745On the marketSingle use

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747176360
Basic UDI-DI: 733274700000020772
Reference: 300082
EMDN: Q010299
EMDN description: PROSTHETIC DENTISTRY DEVICES - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

On1 Screwdriver Manual 25mm

Screwdrivers Ir

Class IMDR 2017/745On the marketDirect markingReusable

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747176292
Basic UDI-DI: 73327470000001787L
Reference: 38753
EMDN: L159099
EMDN description: ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details

Guided Cylinder w Pin Unigrip Bmk Syst NP

Lab tools for surgical templates

Class IMDR 2017/745On the market

Manufacturer: Nobel Biocare AB
Manufacturer SRN: SE-MF-000000009
UDI-DI: 07332747174540
Basic UDI-DI: 733274700000020874
Reference: 32768
EMDN: Q010299
EMDN description: PROSTHETIC DENTISTRY DEVICES - OTHER
First on market country: Sweden
Authorised representative: -
Last updated: 03.07.2026 04:10

Manufacturer products View details