K Number

Device Name

INSIGNIA DIGICAST

Manufacturer

ORMCO CORP.

Date Cleared

2013-03-26

(174 days)

Product Code

DYW EJF NJM

Regulation Number

872.5470

Intended Use

Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Device Description

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment. Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional. The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements. There are no accessories or patient contacting components of Insignia Digicast.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K082207

Reference Devices

K082207

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on digital modeling, scanning, processing, and measurement tools, without mentioning AI or ML algorithms for analysis or diagnosis.

Therapeutic

No
The device is described as a diagnostic aid for orthodontic treatment, primarily used to record the status of a patient's dentition and support diagnosis, not to actively treat a condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" states it is "intended for use as an aid in orthodontic diagnostics". Additionally, the "Device Description" mentions "Clinicians may also use the digital model to support their diagnosis" and "The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements," which are all diagnostic analyses.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "Insignia Digicast is a software product and service" and "There are no accessories or patient contacting components of Insignia Digicast," indicating it is solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Insignia Digicast's Function: Insignia Digicast works with digital models created from scanned traditional impressions of teeth. It provides tools for analyzing these models for orthodontic diagnostics.
Lack of Biological Sample Analysis: The system does not analyze any biological samples taken directly from the patient's body. It processes a digital representation of the teeth.

Therefore, Insignia Digicast falls outside the scope of an In Vitro Diagnostic device. It is a software and service system used for analyzing physical characteristics (the shape and position of teeth) based on a digital model derived from an impression.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DYW, NJM, EJF

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patients' teeth / dentition

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental professionals trained in orthodontic treatment

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

This 510(k) submission includes data from bench testing used to evaluate the performance characteristics of Insignia Digicast compared to the predicate device, OrthoCAD iQ. The characteristics evaluated include, but were not limited to, teeth width, space, T-J Moyers, Bolton, Arch and Overbite/Overjet. The Insignia Digicast software has been successfully validated to confirm the performance of the device. Clinical testing has not been conducted on this product.

Key Metrics

Not Found

Predicate Device(s)

K082207, Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

K123118

Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo consists of the letters "sds" in a bold, sans-serif 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 simple and modern, and the use of bold fonts makes it easily recognizable.

MAR 2 6 2013

510K 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

Date Summary Prepared: March 2013

. Trade name - Insignia Digicast
Common name -Digital Study Model
Classification name Orthodontic Plastic Bracket (21 CFR§872.5470) .
- Product Codes DYW (Orthodontic Plastic Bracket)
  - (Orthodontic Metal Bracket) EJF
  - NJM (Orthodontic Ceramic Bracket)

Device for Which Substantial Equivalence is Claimed:

. Lava Digital Models, Marketed by 3M Unitek Class | Exempt Product Code: LMD (21CFR§892.2020)
OrthoCAD iQ, Marketed by Cadent, Inc. ● Class II Study model described within K082207 DYW (Orthodontic Plastic Bracket, 21CFR§872.5470) Product Code: EJF (Orthodontic Metal Bracket, 21CFR§872.5410) NJM (Orthodontic Ceramic Bracket, 21CFR§872.5470)

Summary

Device Description

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment.

Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional.

KI 23118

The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements.

There are no accessories or patient contacting components of Insignia Digicast.

Indications for Use of the Device

Technological Characteristics Compared to Predicate

Features	Insignia Digicast	OrthoCAD iQ	Lava Digital Model
	Insignia Digicast is a computer
aided system intended for use
as an aid in orthodontic
diagnostics for use by dental
professionals trained in
orthodontic treatment
including radiographic analyses
and diagnostics.	Ortho CAD iQ is a
computer-guided system
intended for use as an aid
in orthodontic treatment
planning for use by dental
professionals trained in
orthodontic treatment
including radiographic
analyses and treatment
planning. OrthoCAD iQ is
intended for use with
commercially-available
brackets and wires that
apply continuous gentle
force to reposition the
teeth. It also uses indirect
bonding trays to affix the
brackets in position.	Lava Digital Models is
a software product
that allows clinicians
to display and interact
with digital study
models for patient
consultations. Lava
Digital Models scans a
traditional impression,
processes the scan
and electronically
delivers the digital
study model to the
dental professional.
The dental
professional may
view, measure and
analyze the digital
study model.
Indications for
Use
Features (cont.)	Insignia Digicast	OrthoCAD iQ	Lava Digital Model
Mode of Use	The Insignia Digicast system
scans a traditional impression,
processes the scan, and
electronically delivers a digital
study model to the dental
professional.	The OrthoCAD iQ system
scans a traditional
impression, processes the
scan, and electronically
delivers a digital study
model to the dental
professional.	The Lava Digital
Models system scans
a traditional
impression, processes
the scan, and
electronically delivers
a digital study model
to the dental
professional.
	Manufacturing
Method	A dental professional takes an
alginate or PVS impression of
the patient's teeth. The
impression is then scanned and
converted into a digital model.
This model is then uploaded for
use by the practitioner.	A dental professional
takes an alginate or PVS
impression of the
patient's teeth The
impression is then
scanned and converted
into a digital model. This
model is then uploaded
for use by the
practitioner.	A dental professional
takes an alginate or
PVS impression of the
patient's teeth The
impression is then
scanned and
converted into a
digital model. This
model is then
uploaded for use by
the practitioner.
		Analyses
Available	The following analyses are
available for use by the dental
practitioner: Bolton Analysis,
Tanaka-Johnston/Moyers
Analysis, Space Analysis, and
ABO Discrepancy Index Scoring.	The following analyses are
available for use by the
dental practitioner:
Bolton Analysis, Tanaka-
Johnston/Moyers
Analysis, Space Analysis,
and ABO Discrepancy
Index Scoring	Instantly obtain point-
to-point
measurements with
automatic calculations
and auto-sums
(Bolton analysis, arch
length, overbite and
overjet)

K123118

Non-Clinical Performance Data

The Insignia Digicast software has been successfully validated to confirm the performance of the device.

Clinical Testing

Clinical testing has not been conducted on this product.

Conclusion

Based upon the similar technological/performance characteristics as compared to the predicate devices, and successful validation of the Insignia Digicast software, the performance of the Insignia Digicast is deemed to be substantially equivalent to the OrthoCAD iQ and Lava Digital Models. Additionally, there are no functional differences between the devices.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 26, 2013

Ormeo Corporation C/O Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties 1717 West Collins Avenue ORANGE CA 92867

Re: K123118

Trade/Device Name: INSIGNIA DIGICAST Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW, NJM, EJF Dated: February 22, 2013 Received: February 25, 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.

Page 2 - Ms. Garman

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,

Kwame O. Ulmer -S
for

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

K123118

Indications for Use

510(k) Number (if known):

Device Name: INSIGNIA DIGICAST

Indications For Use:

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)

Andrew I. Steen Concurrence of Collige of Concerner ation (ODE)

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K123118 510(k) Number:

004_Indications for Use - Page 2 of 2