Country for PR: United States
Contributor: PR Newswire New York
Wednesday, June 16 2021 - 23:05
AsiaNet
Spark(TM) Aligners Receive FDA Clearance For Orthodontic Treatment Of Kids, Giving Parents A New Option With Significant Treatment Advantages Over The Leading Competitor
BREA, Calif., June 16, 2021 /PRNewswire-AsiaNet/ --

-- Newest Doctor-Directed Clear Aligner System For Straightening Teeth Now 
Treats Younger Patients with Both Primary & Secondary Teeth with Simple to 
Complex Orthodontic Issues -- 

Ormco Corporation ( 
https://c212.net/c/link/?t=0&l=en&o=3196081-1&h=4020440547&u=http%3A%2F%2Fwww.ormco.com%2F&a=Ormco+Corporation 
), a global leader of orthodontic solutions, today announced it has received 
U.S. Food and Drug Administration (FDA) clearance for the use of its Spark(TM) 
Clear Aligner System for orthodontic treatment in patients with both primary 
and secondary teeth (mixed dentition), providing the green light for 
orthodontists to treat their younger patients who can benefit from clear 
aligner therapy. 

Photo - https://mma.prnewswire.com/media/1532983/Spark_for_Kids_Teens_II.jpg 
Photo - https://mma.prnewswire.com/media/1532984/Spark_for_Kids_Teens_I.jpg 
Photo - https://mma.prnewswire.com/media/1534026/SparkAligner.jpg 
Logo - https://mma.prnewswire.com/media/1357605/Spark_Logo.jpg 

Designed to fit the lifestyle of today's active kids and teens, Spark Clear 
Aligners are now one of the few brands approved by the FDA to safely and 
effectively treat younger patients with cases that range from simple to more 
complex. Spark Aligners are a doctor-directed treatment option that is clearer, 
more comfortable, and stains less than the leading aligner brand. In fact, 96% 
of patients prefer Spark Clear Aligners to the leading brand based on clarity 
and comfort.1 Spark Aligners have created thousands of healthy smiles worldwide 
since 2019. 

"My son and I have been so happy with his experience using Spark Aligners," 
said Mrs. Strecker, a parent of a 9-year-old who needed treatment for spacing 
as well as AP correction. "Our orthodontist recommended Spark because he 
achieved outstanding results with other patients and told us the material used 
in Spark Aligners would be the clearest option while also being more 
comfortable than the leading competitive alternative. Because people could 
barely notice he was wearing aligners, my son felt confident during his entire 
treatment. We saw his smile change dramatically in about 3 months and treatment 
completion with a beautiful smile in 5 months. We are big Spark fans!"

Spark Aligners are made with TruGEN(TM) material, the latest innovation in 
proprietary branded aligner material. TruGEN resists stains better and is even 
clearer than the leading aligner material. The edges are polished and smoother 
to avoid the occasional discomfort that can result from other aligner brands. 
Unlike online or at-home aligner products that eliminate the important role of 
the orthodontic specialist, Spark Aligners involve an experienced doctor in 
every aspect of treatment.  

"My practice has been impressed with the results we are achieving for our 
patients with Spark Aligners," said Dr. Bill Dischinger* of Dischinger Team 
Orthodontics. "The TruGEN material from which the aligners are made delivers 
better surface contact providing faster and more reliable tooth movements. With 
Spark Aligners, we're seeing stronger and more predictable outcomes than we've 
achieved with other aligners, so the expanded indication of usage is great news 
for my younger patients who lead busy lifestyles filled with sports, music and 
other activities. My entire team and our patients are thrilled with the 
efficient, reliable treatment experience that Spark Aligners deliver."

Doctors worldwide have successfully used Spark Aligners to treat a wide variety 
of patient orthodontic issues including open bite, deep bite, overbite, 
underbite, crossbite, crowding, spacing, semi-erupted teeth and extractions.

"Spark Aligners were made in collaboration with leading orthodontists. This 
along with TruGEN(TM), the most advanced material available, ensures a better 
treatment experience for patients," said Sheila Tan, Vice President of Global 
Marketing & Clinical Education. "We are delighted with the FDA clearance to 
expand our treatment options to include kids and teens. Now Spark Aligners can 
be used to treat young children that do not have all of their permanent teeth."

Parents and other consumers can learn more about the Spark Clear Aligner 
System, view patient before & after images, and find a Spark Aligners doctor at 
https://sparkaligners.com 

About the Spark(TM) Clear Aligner System

Spark(TM) Aligners are manufactured by Ormco(TM), a global leader in innovative 
orthodontics products, with 60 years of orthodontics expertise, R&D and high 
manufacturing standards. Ormco has helped doctors create more than 20 million 
smiles in more than 130 countries. Spark Aligners offer the latest advancements 
in clear aligners and a better patient experience. Spark Approver 3D 
application and advanced clear aligner technology with TruGEN(TM) material is 
designed to meet the needs of orthodontists, providing more efficient and 
effective tooth movement, compared to the leading aligner brand. Spark Aligners 
are designed to give orthodontists more control and flexibility so that they 
can more easily achieve healthy, confident smiles.

Trusted by orthodontists worldwide, Spark Aligners are clearer, more 
comfortable and stain less than the leading aligner brand. Spark Aligners are 
loved by patients: 100 percent of Spark patients surveyed would recommend Spark 
Clear Aligners to a friend.¹  For more information about Spark Aligners, visit 
www.sparkaligners.com.

*Dr. Bill Dischinger is a paid consultant of Ormco. The opinions expressed are 
those of Dr. Dischinger. Ormco is a medical device manufacturer and does not 
dispense medical advice. Clinicians should use their own professional judgment 
in treating their patients.

Basis for Release: Claims Matrix Form 045:

New Indications for Use: "The Spark (TM) Clear Aligner System is indicated for 
the alignment of teeth during orthodontic treatment of malocclusion." Formerly 
the indication was: "The Ormco Spark Clear Aligner System is indicated for the 
treatment of tooth malocclusion in patients with permanent dentition (i.e., all 
second molars). The Ormco Clear Aligner System positions teeth by way of 
continuous gentle force.

3.  Spark(TM) Aligners are a nearly invisible, discrete aligner treatment 
system.

13. Spark Aligners are designed to provide a more comfortable and productive 
treatment. 

17. Spark Clear Aligners are proven to have minimal aligner stains, which helps 
keep your smile shining during treatment.

20. TruGEN(TM) material is proven to provide advanced force retention compared 
the leading aligner material. Force retention has been found to result in more 
increased tooth movement. This may result in more efficient and effective tooth 
movement compared to the leading aligner material.

21. Spark Clear Aligners are designed to be clearer than the leading competitor.

32. "Doctors worldwide are using Spark Clear Aligners to treat a wide variety 
of patient malocclusions including open bite, deep bite, overbite, underbite, 
crossbite, crowding, spacing."

33. 100% of patients surveyed would recommend Spark Aligners to a friend.

40. More clear. More comfortable.

41. Patients agree that Spark Aligners are more comfortable to wear.

MEDIA 
CONTACT:                                                                        
       
Sharon Scott, SparkPR@secondlyco.com
+1 310.594.6545

1 Data on file with Ormco(TM)

SOURCE: Ormco