Nobel Biocare N1™
Nobel Biocare AB · Model 301074
Radiographic Template Nobel Biocare N1™
Intended use: A non-sterile device intended to be used by a dentist or a surgeon to radiographically determine the appropriate size of a dental implant to be inserted into the jawbone of a patient prior to dental surgery. It is typically made of a translucent plastic sheet marked with incremented graduations that correspond to the lengths of the implants available. The device is typically available in a set with graduated markings and an individual sheet is placed over the x-ray of the jawbone so that the final selection of implant size can be determined against the depth of bone shown by the x-ray. This is a reusable device.
Key tips
- ·Never bypass a radiation interlock to "just get the image" - this is one of the few true zero-tolerance rules in BMET work.
- ·Trend image-quality phantom results over time - drift shows up before an outright failure does.
- ·Portable/mobile units take real physical abuse from transport - check wheel locks and cable strain reliefs more often than fixed units.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily QC per modality: image-quality phantom test
- ·Tube and detector inspection
- ·Annual state-required radiation safety survey
- ·Vendor-scheduled preventive maintenance
Technical Specs
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Dental implant x-ray template
- FDA product classification
- Accessories, implant, dental, endosseous
- Manufacturer support
- +1(800)322-5001 · us.customerservice@nobelbiocare.com
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Radiology / Imaging department
- Emergency Department (portable units)
- Operating Room (C-arms)
- Cath lab
- Bedside ICU (portable X-ray)
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.
- RECALL
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
- RECALL
The product label has missing information, such as the lot number and expiration date, as well as other information.
- RECALL
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
- RECALL
Misprinted radiographic template plates. Misprinted labeling.
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