Question 1

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

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Esthetic Zirconia Abutment	K031719	FDA 510(k)	Class II	Active
NobelDesign, DTX Studio Design	K171466	FDA 510(k)	Class II	Active
Teeth In An Hour - Ark Implant Concept	K030685	FDA 510(k)	Class II	Active
DTX Studio Clinic 3.0	K221921	FDA 510(k)	Class II	Active
Multi- Unit Abutments For Straumann And Astra Tech Implant Systems	K093643	FDA 510(k)	Class II	Active
TREFOIL System	K152836	FDA 510(k)	Class II	Active
Nobel Biocare Endosseous Implants (maxillofacial Indication)	K090630	FDA 510(k)	Class II	Active
Procera Zirconia Abutment For Camlog Implant System	K061529	FDA 510(k)	Class II	Active
Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 To 30-4013	K071182	FDA 510(k)	Class II	Active
NobelClinician, DTX Studio implant	K163122	FDA 510(k)	Class II	Active
Nobelprocera Zi Abutment	K091904	FDA 510(k)	Class II	Active
Procera Software, Model 33145	K053602	FDA 510(k)	Class II	Active
On1 Concept	K161655	FDA 510(k)	Class II	Active
Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate	K191475	FDA 510(k)	Class II	Active
Procera Bridge Zirconia	K053125	FDA 510(k)	Class II	Active
Nobeldirect 3.0-Immediate Load, 3.0 X 13 Mm And 3.0 X 15 Mm	K070857	FDA 510(k)	Class II	Active
Nobelprocera Ips E.max Crown	K100512	FDA 510(k)	Class II	Active
DTX Studio design	K181932	FDA 510(k)	Class II	Active
NobelProcera HT ML FCZ Bridge	K162043	FDA 510(k)	Class II	Active
Nobelspeedy Implants	K050406	FDA 510(k)	Class II	Active
Zygoma Implant (immediate Function)	K070182	FDA 510(k)	Class II	Active
Adapter Ps Rp-Np, 34551, Adapter Ps Wp-Rp, 34552, Abutment Screw Ps Rp-Np, 34553, Abutment Screw Ps Wp-Rp, 34554	K063592	FDA 510(k)	Class II	Active
Guided Pin 28mm Bmk Syst RP	32881	EUDAMED	Class I	Active
Guided Sleeve NP	32754	EUDAMEDFDA UDI	Class I	Active
NobelProcera® Zirconia Implant Crown NB N1™ Base OM2 NP	87126	EUDAMEDFDA UDI	Class IIb	Active
NPr FCZ Imp Crown ASC CC RP CAD 1-25° s5	77376	EUDAMEDFDA UDI	Class IIb	Active
Guide Pin Multi-unit Brånemark System® WP 10 mm	31156	EUDAMED	Class I	Active
Universal Base ASC Engaging CC WP 2.5mm Ø4.8	302204	EUDAMED	Class IIb	Active
Brånemark System® Mk III TiU RP 3.75x8.5mm	28912	EUDAMEDFDA UDI	Class IIb	Active
NobelZygoma™ Depth Indicator Straight	301656	EUDAMED	Class I	Active
Screw Tap WP Ø5 7-18mm	32293	EUDAMEDFDA UDI	Class IIa	Active
NobelSpeedy® Groovy RP 5.0x15mm	37690	EUDAMEDFDA UDI	Class IIb	Active
NobelProcera® Zirconia Implant Crown NB N1™ Base D3 NP	87142	EUDAMEDFDA UDI	Class IIb	Active
Bone Mill Guide Conical Connection 3.0	37862	EUDAMEDFDA UDI	Class I	Active
Healing Abutment Bmk Syst WP Ø6x3 mm	29141	EUDAMEDFDA UDI	Class IIb	Active
Rescue Drill Guide Conical Connection 3.0	37485	EUDAMEDFDA UDI	Class I	Active
Lab Screw Tri-Channel RP/WP/6.0	38419	EUDAMEDFDA UDI	Class I	Active
NobelProcera® Titanium ASC Abutment w CC WP	88442	EUDAMEDFDA UDI	Class IIb	Active
Guided Cylinder w Pin Unigrip Bmk Syst WP	32774	EUDAMEDFDA UDI	Class I	Active
Esthetic Abutment Nobel Biocare N1™ Base RP 0.5mm	301002	EUDAMEDFDA UDI	Class IIb	Active
NobelProcera® Zr Implant Bridge 14unit D2	83435	EUDAMEDFDA UDI	Class IIb	Active
Implant Replica Nobel Biocare N1™ TCC RP	300963	EUDAMEDFDA UDI	Class I	Active
Procera® Imp Br Zr Impl Lev 3 unit Light	15-6002-5	EUDAMEDFDA UDI	Class IIb	Active
Multi-unit Abutment Plus Conical Connection NP 3.5mm	38884	EUDAMEDFDA UDI	Class IIb	Active
Protection Analog Multi-unit 5/pkg	29123	EUDAMEDFDA UDI	Class I	Active
NPr FCZ Imp Crown ASC CC NP CAD 1-25° s5	77375	EUDAMEDFDA UDI	Class IIb	Active
Healing Abutment Bmk Syst NP Ø4.5x5mm	33444	EUDAMEDFDA UDI	Class IIb	Active
NobelProcera® Zr Implant Bridge 2unit A3	83280	EUDAMEDFDA UDI	Class IIb	Active
15° Esthetic Abutment Conical Connection RP 1.5mm	36672	EUDAMEDFDA UDI	Class IIb	Active
Procera Implant Bridge Ti Impl Level 11unit	15-1040	EUDAMEDFDA UDI	Class IIb	Active

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