Technology continues to shape the way dentistry is done. Every aspect of the restorative process has changed, from the way a dentist acquires an impression of the patient’s mouth to the fabrication methods utilized in the dental lab. The transition from labor intensive, hands-on fabrication methods of alloy-based restorations to CAD/CAM design and the latest all-ceramic materials has yielded strong and esthetic monolithic restorations in less time and at a lower price. Dental labs also have viable options for producing models digitally in-house versus purchasing CAD/CAM models from another lab/manufacturer or fabricating traditional stone models.
The two basic forms of technology utilized to fabricate restorations and models today are additive (3D printing) and reductive (milling). This article discusses the common types of 3D printing technology utilized in dental labs and illustrates digital model fabrication from a 3D printer with actual cases and different restorative applications.
Με τον Ν.4461/2017 ΦΕΚ 38’Α «Μεταρρύθμιση της Διοικητικής Οργάνωσης των υπηρεσιών ψυχικής υγείας, Κέντρα Εμπειρογνωμοσύνης σπανίων και πολύπλοκων νοσημάτων, τροποποίηση συνταξιοδοτικών ρυθμίσεων του ν.4387/2016 και άλλες διατάξεις», στα άρθρα 54-71 συνιστάται ο ΠΑΝΕΛΛΗΝΙΟΣ ΣΥΛΛΟΓΟΣ ΟΔΟΝΤΟΤΕΧΝΙΤΩΝ (Π.Σ.Ο.)– Ν.Π.Δ.Δ., ο οποίος υπάγεται στην εποπτεία του Υπουργείο Υγείας.
Βάσει των παραπάνω όλοι οι οδοντοτεχνίτες που είναι απόφοιτοι: α) των πρώην Οδοντοτεχνικών Σχολών Κ.Α.Τ.Ε.Ε. και Κ.Α.Τ.Ε., β) των Τμημάτων Οδοντικής Τεχνολογίας των Σχολών Επιστημών Υγείας – Πρόνοιας των Τ.Ε.Ι., γ) των Σχολών ή Τμημάτων της αλλοδαπής των οποίων τα πτυχία έχουν αναγνωριστεί ως ισότιμα με τα πτυχία οδοντοτεχνίτη της ημεδαπής κατά την κείμενη νομοθεσία, δ) οι κάτοχοι άδειας επαγγέλματος οδοντοτεχνίτη, σύμφωνα με το ν. 1666/1986 υποχρεούνται να εγγραφούν στο νέο Σύλλογο.
Homeopathic teething tablets and gels may pose a risk to infants and children and the U.S. Food and Drug Administration recommends that consumers stop using these products and discard any in their possession, according to a news release the FDA issued Sept. 30.
Consumers should seek medical care immediately if their child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation after using homeopathic teething tablets or gels, the FDA said in the news release.
The FDA encourages health care professionals, and consumers, toreport adverse events or quality problems experienced with the use of these tablets and gels, which the agency notes are distributed by CVS, Hyland’s and possibly others, and are sold in retail stores and online.
To submit a report online to the FDA, go online to FDA.gov.
The ADA included this alert in a communication to state executive and other leaders Oct. 4. The Association also added it to a list maintained on ADA.org of Safety Alerts related to dental drugs and devices.
Maybe it’s just that certain dental laboratories that are registered with FDA have come up on what FDA refers to as their “inventory”, but a number of dental labs have been audited in the past two months. Georgia is definitely on the radar so if you’re located in Georgia and are registered with FDA or are involved in activities that require you to register with FDA but you haven’t, then be prepared.
Over the past eight years, articles in JDT Unbound’s Risky Business section have provided you information on the subject of FDA registration, FDA inspections, and qualifying your suppliers and subcontractors. It’s time for you to go back and read those articles so you can ensure that you understand what’s required by FDA in these regards. They are archived in JDT Unbound and appeared in the following months/years:
August 2008: Qualify Your Vendors/Suppliers and/or Subcontractors
January 2010: Know Your Outsourcer!
February 2011: FDA Registration – Fact or Fiction?
September 2012: FDA Revises Medical Device Establishment Registration Fees and Requirements
What seems to be occurring and is definitely a concern is that not all foreign manufacturers are registered correctly. It appears that some will list every FDA Product Code if it has any word in it that refers to a dental material or term. If a foreign dental laboratory actually manufactures porcelain powder, then they would have to have a 510(k) clearance on the material, however, if they are using an FDA cleared porcelain manufactured by Dentsply or Noritake, for instance, then they would not list the porcelain powder on their registration but rather the PFM product code. These product codes usually begin with an “N”.
Why is that important for the U.S. dental laboratory that is importing? Because the U.S. dental laboratory must register with FDA as an importer or repackager/relabeler if they are receiving shipments direct from the foreign manufacturer and list the items being imported which must match the items that the foreign dental lab lists on its registration. The February 2011 article referenced above goes into detail on the product codes and types of listings. Also, the foreign dental lab, as explained in the September 2012 article regarding the changes in FDA registration requirements, must disclose the names of its U.S. customers to FDA. This is another way for FDA to locate the U.S. importers and ensure that they are registered with FDA.
If the foreign manufacturer is registered incorrectly, then that problem can flow down to its U.S. customers who may also be registered incorrectly. In turn, FDA will think the U.S. dental laboratory is doing one thing, when in actuality it is not. The onsite audit by FDA can start out in the wrong direction and create undue stress on the U.S. customer. Do your due diligence on this issue so your inspection by FDA will address the correct activities and products that you’re importing.
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