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Nobel Biocare AB

Sweden·SE-MF-000000009

Last updated September 17, 2026

What Nobel Biocare AB makes

Nobel Biocare AB manufactures single-use dental implant suprastructures, including temporary preformed components like screwdrivers, try-in screws, and replica implants for prosthetic fitting. Their portfolio also includes carbide dental burs designed for one-time use in dental procedures, as well as guided components such as base replicas, protection analogs, and guide pins for implant placement and verification.

The company’s devices are classified under EU Medical Device Regulations as Class I, Class IIa, and Class IIb, with all relevant products registered in the EUDAMED database. Nobel Biocare AB is headquartered in Sweden.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Nobel Biocare AB primarily manufacture?

Nobel Biocare AB specializes in dental implant-related devices, focusing on single-use components. Their portfolio includes temporary preformed dental implant suprastructures like screwdrivers, try-in screws, and replica implants used for prosthetic fitting. Additionally, they produce carbide dental burs for one-time use in dental procedures, as well as guided components such as base replicas, protection analogs, and guide pins for implant placement and verification.

Where is Nobel Biocare AB based, and what does this mean for their regulatory compliance?

Nobel Biocare AB is headquartered in Sweden, which means their devices are subject to EU Medical Device Regulations (MDR). Since they manufacture products listed under Class I, Class IIa, and Class IIb, their devices must comply with these regulations and are registered in the EUDAMED database, the official EU registry for medical devices.

Which regulatory registries list Nobel Biocare AB’s devices, and why is this important?

Nobel Biocare AB’s devices are listed in the EUDAMED database, the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices under the EU Medical Device Regulations, allowing healthcare professionals, regulators, and patients to verify the legal status and classification of their products.

How are Nobel Biocare AB’s devices classified under EU regulations, and what does this classification indicate?

Nobel Biocare AB’s devices fall under Class I, Class IIa, and Class IIb classifications under the EU Medical Device Regulations. This classification determines the level of scrutiny and regulatory requirements for each product—Class I devices are generally low-risk, while Class IIa and IIb involve higher risks and require additional safety and performance evaluations before authorization.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Sweden
Address
1, Västra Hamngatan , Göteborg, Sweden
Website
nobelbiocare.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+1(800)322-5001
PRRC Contact
Stefan Trampler
EUDAMED SRN
SE-MF-000000009
FDA FEI Number
3002807692
DUNS Number
353939929

Catalogue (3532)

Page 14 of 71
DeviceModel / ReferenceRegistriesClassStatus
NobelProcera® Zr Implant Bridge 3unit A3 83281
EUDAMEDFDA UDI
Class IIbActive
17° Multi-unit Abutment Xeal™ Conical Connection RP 2.5mm 300182
EUDAMEDFDA UDI
Class IIbActive
Bone Mill with Guide Conical Connection 3.0 Ø4.0 37861
EUDAMEDFDA UDI
Class IIaActive
Lab Screw Multi-unit Angled NobRpl RP 31167
EUDAMEDFDA UDI
Class IActive
Kit Boxes and Kit Plates K163600
FDA 510(k)
Class IIActive
DTX Studio Clinic 3.0 K213562
FDA 510(k)
Class IIActive
Groovy Implants K050258
FDA 510(k)
Class IIActive
Molar Implant K081128
FDA 510(k)
Class IIActive
Nobelactive Multi Unit Abutment K072570
FDA 510(k)
Class IIActive
Multi-Unit Abutments For Astratech, Camlog And Ankylos Implant Systems K061477
FDA 510(k)
Class IIActive
Various Branemark System Implants-Immediate Function Indication K022562
FDA 510(k)
Class IIActive
Nobelprocera Peek Abutments K120954
FDA 510(k)
Class IIActive
Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 K043042
FDA 510(k)
Class IIActive
Nobelactive Internal Connection Implant K071370
FDA 510(k)
Class IIActive
NobelProcera HT ML Full Contour Zirconia Crown K153534
FDA 510(k)
Class IIActive
NobelDesign Software K153036
FDA 510(k)
Class IIActive
Nobelactive Zirconia Abutment K072129
FDA 510(k)
Class IIActive
Carbon Fiber Bridge, Model 28757 K031070
FDA 510(k)
Class IIActive
The Guided Surgery Concept K050393
FDA 510(k)
Class IIActive
Nobelperfect Conical Connection K062936
FDA 510(k)
Class IIActive
Procera Titanium Abutment For Astratech And Camlog Implant Systems K061478
FDA 510(k)
Class IIActive
Nobelactive Wide Platform (wp) K133731
FDA 510(k)
Class IIActive
15 Esthetic Abutment Nobelactive 03.0 1.5mm, 15 Esthetic Abutment Nobelactive 03.0 3mm, 15 Esthetic Abutment Nobelactive K111581
FDA 510(k)
Class IIActive
Sfb And Cfb Implants - 5.0 Platform K063718
FDA 510(k)
Class IIActive
Procera Bridge Laminate, Model 40-4002 K053068
FDA 510(k)
Class IIActive
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium K233208
FDA 510(k)
Class IIActive
Nobelprocera Angulated Screw Channel Abutment Replace K133377
FDA 510(k)
Class IIActive
Sbf 15 Esthetic Abutment 1mm Np, Model 33699, Sfb 15 Esthetic Abutment 1mm Rp, Model 33701, Cfb 15 Esthetic Abutment 2mm K062749
FDA 510(k)
Class IIActive
Nobelactive 3.0 Goldadapt Abutments K112259
FDA 510(k)
Class IIActive
Nobel Biocare S Series Implants K252197
FDA 510(k)
Class IIActive
Procera Bridge Alumina K053050
FDA 510(k)
Class IIActive
DTX Studio Clinic (4.0) K231898
FDA 510(k)
Class IIActive
TREFOIL System K172352
FDA 510(k)
Class IIActive
Procera Bridge Zirconia K041283
FDA 510(k)
Class IIActive
Procera Implant Bridge Zirconia K053091
FDA 510(k)
Class IIActive
Nobelprocera Ti Abutment Camlog Platforms K122602
FDA 510(k)
Class IIActive
Nobelprocera Ti Abutment Thommen Platforms K101714
FDA 510(k)
Class IIActive
DTX Studio diagnose K172224
FDA 510(k)FDA UDI
Class IIActive
Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 K041236
FDA 510(k)
Class IIActive
Nobelperfect Conical Connection Hexagonal Implants K072980
FDA 510(k)
Class IIActive
NobelProcera HT ML FCZ Implant Bridge and Framework K160158
FDA 510(k)
Class IIActive
NobelZygoma TiUltra Implant system K243834
FDA 510(k)
Class IIActive
Tiunite Implants K050705
FDA 510(k)
Class IIActive
Sfb & Cfb Implants K061003
FDA 510(k)
Class IIActive
Procera Implant Bridge Overdenture K090069
FDA 510(k)
Class IIActive
TiUltra Implants and Xeal Abutments K202344
FDA 510(k)
Class IIActive
TREFOIL System K170135
FDA 510(k)
Class IIActive
Nobelclinician K123976
FDA 510(k)
Class IIActive
Titanium Abutment Blank Nobel Biocare N1 TCC K223677
FDA 510(k)
Class IIActive
Proceara Copings And Pontic K032562
FDA 510(k)
Class IIActive

Related Companies

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Nobel Biocare AG US