(127 days)
Not Found
No
The description focuses on software for calculating bracket positions based on orthodontist input and digital scans, without mentioning AI or ML algorithms for analysis or decision-making.
Yes
The device is used to correct "malocclusions in orthodontic patients," which involves treating a medical condition to improve health.
No
The device is described as treatment planning software and an orthodontic appliance system used to correct malocclusions. While it uses tooth data to create models for treatment, its primary function is planning and facilitating treatment, not diagnosing a condition.
No
The device description explicitly lists hardware components (brackets, jigs, archwires) as part of the Insignia with iTero system, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Insignia with iTero system is used for treatment planning and the creation of orthodontic appliances to correct malocclusions. It uses digital scans or impressions of the patient's teeth to create a model and plan the placement of brackets and wires.
- Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the patient's body. It works with physical or digital representations of the patient's teeth.
- Focus on Treatment Planning and Appliance Manufacturing: The primary function is to aid in the planning of orthodontic treatment and the manufacturing of customized appliances, not to diagnose or provide information based on biological samples.
Therefore, the Insignia with iTero system falls under the category of a medical device used for treatment planning and the creation of patient-specific orthodontic appliances, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.
The Insignia Orthodontic System is compatible with the iTero scanner.
Product codes (comma separated list FDA assigned to the subject device)
DYW, NJM, EJF
Device Description
The Insignia software creates a computer model of the patient's dentition based on a stone model, iTero scan file or impression of the patient's dentition. The iTero scanner produces a digital scan of a patient's tooth data as an alternative to the physical dental impressions. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive.
Insignia with iTero consists of the following components and accessories:
-
Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist.
-
Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets.
-
Patient-specific foam bracket placement jigs to affix the brackets in position.
-
Either commercially-available or patient-specific shaped traditional archwires.
The device does not include the adhesive that affixes the brackets to the teeth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital impressions (iTero scanner), stone model or dental impression
Anatomical Site
Dentition/teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthodontists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Data: Accuracy testing of the digital impression file generated from the iTero scanner has been successfully verified to confirm the performance of the device.
Clinical Test Data: Clinical testing has not been conducted on this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is black and white.
MAR 1 3 2013
510(k) Summary
Submitter:
Sybron Dental Specialties, Inc. 1717 West Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person
March 2013 Date Summary Prepared:
Device Name:
- Trade Name Insignia with iTero .
- Common Name Accessory to Orthodontic Brackets .
- Classification Name Orthodontic Plastic Bracket, per 21 CFR § 872.5470 ●
- Product Codes Orthodontic Plastic Bracket (DYW), Orthodontic Ceramic Bracket (NJM) and . Orthodontic Metal Bracket (EJF)
Devices for Which Substantial Equivalence is Claimed:
- . Insignia, Ormco Corporation, K121524
- Biomet 31 Patient Specific Dental Abutments (Encode) Designed Using Cadent iTero Scanner . and inLab Software Version v.3.5, K102209
Device Description:
The Insignia software creates a computer model of the patient's dentition based on a stone model, iTero scan file or impression of the patient's dentition. The iTero scanner produces a digital scan of a patient's tooth data as an alternative to the physical dental impressions. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's
1
- teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive.
Insignia with iTero consists of the following components and accessories:
-
Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist.
-
Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets.
-
Patient-specific foam bracket placement jigs to affix the brackets in position.
-
Either commercially-available or patient-specific shaped traditional archwires.
The device does not include the adhesive that affixes the brackets to the teeth.
Indications for Use:
Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.
The Insignia Orthodontic System is compatible with the iTero scanner.
Summary of Technological Characteristics:
Insignia with iTero is substantially equivalent to two other legally marketed devices in the United States. Insignia with iTero functions in a manner similar to and is intended for the same use as Insignia that is currently marketed by Ormco. Additionally, the iTero scanner used with Insignia is the same device that is used by Biomet 3i to manufacture the patient-specific dental abutments as described in below.
| Features | Insignia With iTero | Insignia (K121524) | Biomet 3i Using
Cadent iTero
Scanner(K102209) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | Insignia with iTero is a
treatment planning
software and orthodontic
appliance system used to
correct malocclusions in
orthodontic patients,
using appliances
individualized for the
orthodontic patient. | The Insignia Orthodontic
System is a treatment
planning software and
orthodontic appliance
system used to correct
malocclusions in
orthodontic patients,
using appliances
individualized for the
orthodontic patient. | Biomet 3i Using
Cadent iTero Scanner
is intended for use as
an accessory to
endosseous dental
implants to support a
prosthetic device in a
partially or edentulous
patient. These are
intended for use to |
| Features | Insignia With iTero | Insignia (K121524) | Biomet 3i Using
Cadent iTero
Scanner(K102209) |
| | The Insignia Orthodontic
System is compatible with
the iTero scanner. | | support single and
multiple tooth
prostheses, in the
mandible or maxilla.
The prostheses can be
screw or cement
retained to the
abutment. |
| Sequence of
Treatment
Plan | A 3D digital model is
created based on a
stone model or a
patient's dental
impression or an
alternate digital
impression file
generated from the
iTero scanner is
created and
forwarded to Ormco. A 3D end-of-
treatment outcome
model is generated The 3D model is sent
to the orthodontist for
review Foam bracket
placement jigs are
manufactured to
position the brackets
on the patient's teeth
as prescribed by the
orthodontist Brackets are adhered
to the patient's teeth | A 3D digital model is
created based on a
stone model or a
patient's dental
impression A 3D end-of-
treatment outcome
model is generated The 3D model is sent
to the orthodontist
for review Foam bracket
placement jigs are
manufactured to
position the brackets
on the patient's teeth
as prescribed by the
orthodontist Brackets are adhered
to the patient's teeth | A digital
impression file
generated from
the iTero scanner
is created. The digital file is
electronically sent
to Biomet 3i to
design and mill the
final abutment. |
| Features | Insignia With iTero | Insignia (K121524) | Biomet 3i Using
Cadent iTero
Scanner(K102209) |
| Manufacturing
Method | Final desired arrangement
of teeth, brackets, wires
and jigs are designed with
the guidance of computer
software using 3-
dimensional models of
the patient. In-office
software allows the
clinician to review, alter
and approve desired
result and appliances.
Software generates code
that drives machinery to
manufacture the
appliances. | Final desired
arrangement of teeth,
brackets, wires and jigs
are designed with the
guidance of computer
software using 3-
dimensional models of
the patient. In-office
software allows the
clinician to review, alter
and approve desired
result and appliances.
Software generates code
that drives machinery to
manufacture the
appliances. | Not applicable. |
2
.
3
Non-Clinical Test Data:
Accuracy testing of the digital impression file generated from the iTero scanner has been successfully verified to confirm the performance of the device.
Clinical Test Data:
Clinical testing has not been conducted on this product.
Conclusion:
Based upon the accuracy testing to the predicate device, Insignia, the performance of Insignia with iTero is deemed to be substantially equivalent.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 13, 2013
Ormco Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties 1717 West Collins Avenue ORANGE CA 92867
Re: K123416
Trade/Device Name: Insignia with iTero Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW, NJM, EJF Dated: January 28, 2013 Received: January 31, 2013
Dear Ms. Garman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
5
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/5/Picture/6 description: The image shows the name "Kwame O. Ulmer" superimposed over a stylized FDA logo. The name is written in a bold, sans-serif font, making it easily readable. The FDA logo is rendered in a line art style, with multiple parallel lines creating a three-dimensional effect.
Anthony D. Watson. B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
kl23416 510(k) Number (if known):
Device Name: Insignia with iTero
Indications For Use:
Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.
The Insignia Orthodontic System is compatible with the iTero scanner.
Prescription Use × {Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lary S. Runner -S ·47 -04'00'
hesiology, General Hospital Infection Control, Den
510(k) Number: