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Frequently Asked Questions | Dental Lab Quality System

Dental Lab Quality System FAQ's

Get answers to your dental compliance questions concerning quality systems in the dental lab.

What does a dental lab need to know about 510(k)?

A 510(k) is the section of Food Drug and Cosmetic Act that requires manufacturers to notify FDA of their intent to market a medical device. Manufacturers must submit a 510(k) and the FDA issues an order stating that the device may be marketed. Only materials that are compliant with FDA regulations may be used. Porcelain, ingots, zirconia, acrylic, denture teeth, sleep apnea appliances and implant abutments (both stock and custom) are Class II devices and require a 510(k). Dental labs are only required to have a 510(k) if they want to manufacture any of these items listed. Read more about this here.

Who is getting inspected?

An FDA representative stated that when you register, you are put into "investigational inventory" and at some point in time you will be inspected.

What should classify as a "customer complaint"?

A remake is a complaint, but other issues should also be logged in as complaints such as:

  • Any negative comments regarding the service in general
  • Late delivery time
  • Rude behavior on behalf of the lab
  • Condition of case when it arrived at the client site

All complaints require corrective action with the corrective action being documented. Complaints need to be reviewed on a scheduled basis with corrective action taken noted.

What do you have to do to evaluate a vendor/supplier?

The lab must have a formal system in place for the evaluation of all vendors, suppliers, and subcontractors. These evaluation forms must be reviewed initially upon receipt to determine if the supplier/subcontractor meets the lab’s requirements. After that initial evaluation, then we recommend that a formal review be conducted again each two years.

Do you have to do a formal evaluation of suppliers/vendors that you have used for years?

You must be able to produce a list of all of your suppliers/subcontractors and the names of the materials you purchase from them. The list should show why you do business with the supplier/subcontractor. We've been told by the FDA that showing "historical relationship" as reason for doing business is not acceptable as the only reason.

How do you show the competency of your workers?

At a minimum you should have an employment application or resume showing the work experience of each worker. Tracking internal reworks to technicians will provide a system for determining when additional training is required. All training whether in-house or with outside resources must be documented.

How do you determine the effectiveness of your quality system?

Each year you must conduct an internal audit. This can be conducted by your own staff as long as they are not auditing a system that they are involved in. You can hire a firm such as SafeLink to conduct an External Audit and it is highly recommended that each year you have someone from outside your lab conduct an audit. At a minimum of annually, you must conduct a Management Review Meeting. In that meeting, the quality team, and it must include the Lab Owner/President/CEO, must review all of the quality records to determine the effectiveness of the quality system.

How do you track lot numbers and batch numbers of materials?

At a minimum you should track the lot numbers of patient contact materials. This would include porcelain, acrylic, denture teeth, implants, zirconia blocks/cylinders, alloys. You should test your system to ensure that you can track the lot numbers by each case. The reason for this is that if there is a recall of any of these materials, you must be able to determine which dentists need to be notified so they can notify the appropriate patients.

How do I track the lot numbers for subcontracted work such as copings, partial frameworks, PRM’s, etc.?

You must qualify your subcontractors by having them inform you in writing that they are tracking the lot numbers and can relay that information to you should there be a recall. FDA may ask you if you have visited the facility where your subcontracted work is manufactured. This is a part of your due diligence in determining whether or not to do business with a subcontractor. If that subcontractor is in another country, then it is just as important for you to do your due diligence prior to accepting work from that subcontractor.

Are all dental laboratories required to have a Quality System?

If you manufacture dental devices you must comply with the appropriate parts of FDA Quality System Regulation. Even a one person dental lab must have a documented and effective quality system. See FDA’s website for the Quality System Regulation www.fda.gov

What documents require control and control numbers?

All documents that are a part of your service to your dental clients and are a part of your quality system require control and control numbers. This would include your prescription, work tickets, invoices, purchase order forms, standard operating procedures, work instructions, training documentation, equipment maintenance records, facility cleaning records, etc.

As a dental laboratory, do I have to register with FDA?

At this time, all dental labs do not have to register with FDA, however, depending on your business model you may have practices in place that would require you to register. If you are an initial importer or repackage/re-label outsourced work from a foreign lab, then you are required to register. If you manufacturer sleep apnea devices or snore guards you are required to register. This is a very complex issue so it’s best to contact us to discuss your specific requirements.

 

 
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