K Number

Device Name

3M TRUE DEFINITION SCANNER

Manufacturer

3M COMPANY

Date Cleared

2012-11-20

(99 days)

Product Code

NOF

Regulation Number

872.3661

Intended Use

3M True Definition Scanner is an optical impression system used to record the topographical characteristics of the dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate). The three dimensional (3D) model generated from the scan may be further used for the design and manufacturing of dental restorations including implant supported prostheses and partial frameworks, and can be used to design and manufacture physical models of the teeth. It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

Device Description

The 3M True Definition Scanner is a digital impression generating system consisting of a computer system on a mobile cart, a lightweight scanning wand, and embedded software (including firmware). Accessory items include a contrast powder to be applied to the patient's teeth and/or oral anatomy and a battery powered powder sprayer. The computer system consists of a commercial off-the-shelf personal computer (PC) and a touch screen monitor. The scanning wand is a hand held optical device that captures high-resolution video images, in real time, as the patient is being scanned. The wand contains an optical system comprised of low intensity LED's, a light sensor, a lens and supporting electronics. The wand is connected to the cart via a high speed data transfer cable. The wand is designed to be easily maneuvered inside the patient's mouth and captures video imagery at 20 frames per second. Those images are converted to 3D data sets and displayed in real time. The software contains high-speed image processing algorithms, real-time modeling, case management, and archival functionality. 3M True Definition Scanner facilitates a digital workflow which reduces or eliminates many steps traditionally required by the dentist and lab, including tray selection, plaster pouring, material dispensing, base & pin, material setting, die cutting, trimming, articulation, packaging and shipping.

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

K073199, K081961

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "high-speed image processing algorithms" and "real-time modeling," which are common in digital imaging systems but do not inherently indicate the use of AI/ML. There is no mention of AI, ML, deep learning, or any related terms, nor is there information about training or test sets typically associated with AI/ML development.

Therapeutic

No.
The README indicates that the device is an optical impression system used to record topographical characteristics of the dentition and oral anatomy for dental restorations and orthodontic appliances. It does not exert a therapeutic effect on the patient.

Diagnostic

The device is an optical impression system that records topographical characteristics of dentition and oral anatomy to generate 3D models for the design and manufacturing of dental restorations and orthodontic appliances. It does not provide medical diagnoses or interpret clinical signs/symptoms.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of a computer system, a scanning wand (a handheld optical device with hardware components), and embedded software. It is a system with both hardware and software components, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the 3M True Definition Scanner is not an IVD (In Vitro Diagnostic) device.

Here's why:

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The 3M True Definition Scanner directly scans the patient's oral anatomy and dentition. It does not analyze biological samples.
The intended use is to record topographical characteristics and generate 3D models for the design and manufacturing of dental restorations and appliances. This is a process related to creating physical objects based on the patient's anatomy, not diagnosing a medical condition through the analysis of biological samples.
The device description focuses on optical scanning technology and image processing to create a digital representation of the oral cavity. This aligns with a medical device used for imaging and modeling, not an IVD device used for laboratory analysis.

Therefore, the 3M True Definition Scanner falls under the category of a medical device, specifically an optical impression system for dental applications, rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

Product codes (comma separated list FDA assigned to the subject device)

NOF

Device Description

The 3M True Definition Scanner is a digital impression generating system consisting of a computer system on a mobile cart, a lightweight scanning wand, and embedded software (including firmware). Accessory items include a contrast powder to be applied to the patient's teeth and/or oral anatomy and a battery powered powder sprayer.
The computer system consists of a commercial off-the-shelf personal computer (PC) and a touch screen monitor.
The scanning wand is a hand held optical device that captures high-resolution video images, in real time, as the patient is being scanned. The wand contains an optical system comprised of low intensity LED's, a light sensor, a lens and supporting electronics. The wand is connected to the cart via a high speed data transfer cable. The wand is designed to be easily maneuvered inside the patient's mouth and captures video imagery at 20 frames per second. Those images are converted to 3D data sets and displayed in real time.
The software contains high-speed image processing algorithms, real-time modeling, case management, and archival functionality.
3M True Definition Scanner facilitates a digital workflow which reduces or eliminates many steps traditionally required by the dentist and lab, including tray selection, plaster pouring, material dispensing, base & pin, material setting, die cutting, trimming, articulation, packaging and shipping.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Optical

Anatomical Site

dentition and/or full arch and preparation areas (including features such as implant scan locator fixtures, braces, brackets, etc.). In addition it can record the topographical characteristics of the oral anatomy (such as soft tissue, gingivae and palate).

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dentist, Dental laboratories

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 Testing: 3M successfully performed software verification and validation activities including testing of the device's accuracy, case processing, data management, fault management, network access and remote service, patient, doctor and prescription management, scanning operations and workflows to laboratories and mills. Results of accuracy testing are shown in the Substantial Equivalence summary below.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy Comparison:
Initial Average Error (%): 0.13%
Initial Max Error (%): 0.22%

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.

K073199, K081961

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

Regulation Number and Section

§ 872.3661 Optical Impression Systems for CAD/CAM.

(a)
Identification. An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.(b)
Classification. Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).

Summary

122467

3M ESPE Dental Products 3M Center St. Paul, MN 55144-1000 651 733 1110

NOV 2 0 2012

Image /page/0/Picture/4 description: The image shows the logo for 3M ESPE. The logo is in black and white. The text is in a sans-serif font.

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

510(k) Submitter .............................. 3M Company 3M ESPE Dental Products 3M Center, 275-2W-08 2510 Conway Avenue St. Paul, MN 55144-1000 USA Contact person .......................................... Ginger Cantor, RAC Regulatory Affairs Advanced Specialist Phone: (651) 733-1317 Fax: (651) 737-9665 gcantor@mmm.com Date Summary was Prepared .......... November 16, 2012 Trade Name ................................................................................................................................................................... Common Name(s) ..............................Intra-Oral Scanner Recommended Classification ........... Optical Impression Systems for

CAD/CAM, Class II device, (21 CFR § 872.3661, Product Code: NOF)

3M True Definition Scanner 510k 510(k) Summary, November 16, 2012 3M ESPE Dental Products

Predicate Devices:

3MTM ESPETM Lava Chairside Oral Scanner (C.O.S.), K073199 3MTM Unitek™ Lava Chairside Oral Scanner (C.O.S.), K081961

Description of Device:

The computer system consists of a commercial off-the-shelf personal computer (PC) and a touch screen monitor.

The scanning wand is a hand held optical device that captures high-resolution video images, in real time, as the patient is being scanned. The wand contains an optical system comprised of low intensity LED's, a light sensor, a lens and supporting electronics. The wand is connected to the cart via a high speed data transfer cable. The wand is designed to be easily maneuvered inside the patient's mouth and captures video imagery at 20 frames per second. Those images are converted to 3D data sets and displayed in real time.

The software contains high-speed image processing algorithms, real-time modeling, case management, and archival functionality.

3M True Definition Scanner facilitates a digital workflow which reduces or eliminates many steps traditionally required by the dentist and lab, including tray selection, plaster pouring, material dispensing, base & pin, material setting, die cutting, trimming, articulation, packaging and shipping.

Indications for Use:

It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

Electrical Safety/Electromagnetic Compatibility (EMC)

3M ESPE provided data in the 510(k) to demonstrate the device meets the requirements of ANSI/AAMI ES60601-1:2005 (i.e., IEC 60601-1: 2005), Medical electrical equipment - Part1: General requirements for basic safety and essential performance, IEC60601-1:1998 + A1:1992 + A1:1995, Medical electrical equipment – Part 1: General requirements for safety, and IEC 60601-1-2: 2007, Medical Electrical Equipment -Part 1: General Requirements for Safety: Collateral Standard: Electromagnetic Compatibility Requirements and Tests.

In addition, information was provided in the 510(k) to demonstrate the 3M True Definition Scanner meets the requirements of IEC62471:2006, Photobiological safety of lamps and lamp systems.

3M concludes that the 3M True Definition Scanner is safe for its intended use/indications for use.

Biocompatibility

3M provided data in this 510(k) to demonstrate the 3M True Definition Scanner meets the requirements of relevant parts of ISO10993-1(2009), Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process and that the device meets the requirements of ISO 7405: 2008, Dentistry -- Evaluation of biocompatibility of medical devices used in dentistry.

Non-Clinical Testing

3M successfully performed software verification and validation activities including testing of the device's accuracy, case processing, data management, fault management, network access and remote service, patient, doctor and prescription management, scanning operations and workflows to laboratories and mills. Results of accuracy testing are shown in the Substantial Equivalence summary below.

Substantial Equivalence:

3M ESPE's evaluation of the substantial equivalence of the True Definition Scanner to the Lava C.O.S. predicates was based on a comparison of device classification, intended use and indications for use, contraindications, labeling, technological attributes, accuracy, and accessories. 3M also compared risks and End-of Useful Life for both devices.

Comparison of Intended Use/Indications for Use/Contraindications
Feature	3M True Definition
Scanner
(FDA 510(k)# K122467)	3M ESPE Lava C.O.S.
(FDA 510(k)# K073199)	3M Unitek Lava C.O.S.
(FDA 510(k)# K081961)
Procode	NOF	NOF	NOF
Classification	Optical Impression
System for CAD/CAM
21 CFR §872.3661	Optical Impression
System for CAD/CAM
21 CFR §872.3661	Optical Impression System
for CAD/CAM
21 CFR §872.3661
Indications for Use	3M True Definition
Scanner is an optical
impression system used to
record the topographical
characteristics of the
dentition and/or full arch
and preparation areas
(including items such as
implant scan locator
fixtures, braces, brackets,
etc.). In addition, it can
record the topological
characteristics of the oral
anatomy (such as soft
tissue, gingivae, and
palate).

The three dimensional
(3D) model generated
from the scan may be
further used for the design
and manufacturing of
dental restorations
including implant
supported prostheses and
partial frameworks, and
can be used to design and
manufacture physical
models of the teeth.
It may also be used in
conjunction with the
production of orthodontic
appliances, retainers and
accessories. | The 3M ESPE Lava
Chairside Oral Scanner
(C.O.S.) is an optical
impression system
(CAD/CAM) used to
record the topographical
characteristics of teeth. | The 3M Unitek Lava
Chairside Oral Scanner
(C.O.S.) is an optical
impression system
(CAD/CAM) used to record
the topographical
characteristics of teeth.

Technological Comparison
Item	3M True Definition
Scanner
(K122467)	Lava C.O.S.
(510(k)# K073199)	Lava C.O.S.
(510(k)# K081961)
Operating System	Fedora 15 (Linux)	Custom Gentoo Linux	Custom Gentoo Linux
Computer Hardware	Intel XEON processor -
closed system	AMD based processor -
closed system	AMD based processor - closed
system
Internet
Communications	Wireless 802.11 b/g/n	Wireless 802.11 b/g/n	Wireless 802.11 b/
g/n
Scanning Wand
Computer Interface	USB 3.0 Interface	Proprietary serial
interface to custom PCI
adapter	Proprietary serial interface to
custom PCI adapter
Scanning Wand
Imaging Sensor(s)	Single	Three	Three
Scanning Wand	6 LEDs	192 LEDs	192 LEDs
LEDs (# and
wavelength)	(465 nm wavelength)	(465 nm wavelength)	(465 nm wavelength)
Isolation Transformer	Powertronix Isolation
StationTM	Custom built	Custom built

Accuracy Comparison
Parameter	3M True Definition Scanner
(K122467)	Lava COS
(K073199 and K081961)
Initial Average
Error (%)	0.13%	0.57%
Initial Max Error
(%)	0.22%	0.74%

: 上一篇:

Accessories Comparison
Item	3M True Definition
Scanner
(K122467)	3M ESPE Lava
C.O.S.
(510(k)# K073199)	3M Unitek Lava
C.O.S.
(510(k) #081961)	Comments
Contrast
patterning
Powder	Composition:
• titanium dioxide
• amorphous silica
• aluminium
hydroxide
• synthetic
• amorphous silica	Composition:
• titanium dioxide
• amorphous silica
• aluminium
hydroxide
• synthetic
• amorphous silica	Composition:
• titanium dioxide
• amorphous silica
• aluminium
hydroxide
• synthetic
• amorphous silica	No change- the
same powder
described in
K073199 was
used in K081961
and will be used
for the 3M True
Definition
Scanner
Powder delivery
device	Battery (9V) powered
sprayer	Battery (9V) powered
sprayer	Battery (9V) powered
sprayer	No change - the
same sprayer
described in
K073199 was
used in K081961
and will be used
for the 3M True
Definition
Scanner

3M ESPE concludes that 3M True Definition Scanner is substantially equivalent to the named predicate devices (3M ESPE Lava C.O.S. (K073199) and 3M Unitek Lava C.O.S (K081961)). Any differences between the 3M True Definition Scanner and the predicate(s) do not raise new questions of safety or efficacy.

Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or an abstract human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 20, 2012

3M Company C/O Mr. Mark Job Regulatory Technology Services, Limited Liability Company 1394 25TH Street, North West Buffalo, Minnesota 55313

Re: K122467

Trade/Device Name: 3M True Definition Scanner (Model G5) Regulation Number: 21 CFR 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: NOF Dated: November 2, 2012 Received: November 5, 2012

Dear Mr. Job:

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 - Mr. Job

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. Ulme

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

Indications for Use

510(k) Number (if known): K122467

Device Name: 3M True Definition Scanner (Model G5)

Indications for Use:

It may also be used in conjunction with production of orthodontic appliances, retainers and accessories.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runner DDS, MA >05'00' 2012.11.20 12:13:34

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Division of Atlest.ico.org/?
Infection Control, Dental Devices

K122467 510(k) Number:

3M True Definition Scanner 510(k) 02 July 2012

3M ESPE Dental Products