(58 days)
Not Found
No
The description focuses on standard optical scanning and 3D model creation software, with no mention of AI or ML algorithms for image processing, analysis, or model generation. The changes described relate to adapting the software for a new intended use (orthodontic appliances) and do not indicate the introduction of AI/ML.
No
The device is an optical impression system used to record anatomical characteristics and generate 3D models for orthodontic appliances; it does not treat or affect the body directly.
No
The device is described as an "optical impression system" used to "record the topographical characteristics of teeth" and generate "3D images" for the purpose of producing "orthodontic appliances, retainers and accessories." It does not mention any function related to diagnosing diseases, conditions, or injuries.
No
The device description explicitly states the system consists of a computer, proprietary software, and a hand-held dental 'wand' for scanning, indicating it includes hardware components beyond just software.
Based on the provided text, the 3M™ Unitek™ Lava™ Chairside Oral Scanner 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.
- Device Function: The description clearly states that the device is an "optical impression system" used to "record the topographical characteristics of teeth." It creates a 3D model of the teeth based on images captured directly from the patient's mouth.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples taken from the body. It works by scanning the physical structure of the teeth.
- Intended Use: The intended use is for generating data that can be used in the production of orthodontic appliances, retainers, and accessories. This is a mechanical/fabrication application, not a diagnostic one based on analyzing biological samples.
Therefore, the 3M™ Unitek™ Lava™ Chairside Oral Scanner falls under the category of a dental device used for imaging and modeling, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 3M™ Unitek™ Lava™ Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth. Data generated from the 3M™ / Unitek ™ Lava™ Chairside Oral Scanner may be used in conjunction with the production of orthodontic appliances, retainers and accessories.
Product codes
NOF
Device Description
The 3M™ Unitek™ Lava™ Chairside Oral Scanner is a system intended to obtain 3D images of the topographical characteristics of Teeth. The System consists of a computer, proprietary software and a hand held dental 'wand' for scanning the surface of the teeth.
Using the wand in close proximity to the teeth, the image of the teeth is communicated to the software and a 3D model is created by the software. The 3D model is then stored on disk along with pertinent patient information.
In this 510K pre-market notification, the software has been modified to adapt to the revised intended use statement, which adds a new device with the application of generating models for orthodontic appliances, retainers and accessories. An analysis of the changes to the device along with In-Vitro test data demonstrates that no new issues of safety or effectiveness are raised by the changes to the device discussed in this premarket notification.
The 3M™ Unitek™ Lava™ Chairside Oral Scanner will be manufactured by Brontes Technologies, Inc., a 3M Company, and distributed by 3M Unitek, another 3M Company,
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical impression system
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
§ 872.3661 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).
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Page 16 of 174
SEP - 5 2008
5.0 510K Summary
Applicant: Brontes Technologies, Inc. (A 3M Company) 10 Maguire Road, Suite 310 Lexington, MA 02421 Tel: (781) 541-5200
Contact: Mark Olsen
510(k) Numbers and Product Codes of equivalent devices:
Brontes Technologies, Inc. (A 3M Company), Lexington, MA 3M™ ESPE Lava™ Chairside Oral Scanner Code: NOF; K073199 1
Indications for Use
The 3M™ Unitek™ Lava™ Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth. Data generated from the 3M™ / Unitek ™ Lava™ Chairside Oral Scanner may be used in conjunction with the production of orthodontic appliances, retainers and accessories.
Device Description
The 3M™ Unitek™ Lava™ Chairside Oral Scanner is a system intended to obtain 3D images of the topographical characteristics of Teeth. The System consists of a computer, proprietary software and a hand held dental 'wand' for scanning the surface of the teeth.
Using the wand in close proximity to the teeth, the image of the teeth is communicated to the software and a 3D model is created by the software. The 3D model is then stored on disk along with pertinent patient information.
In this 510K pre-market notification, the software has been modified to adapt to the revised intended use statement, which adds a new device with the application of generating models for orthodontic appliances, retainers and accessories. An analysis of the changes to the device along with In-Vitro test data demonstrates that no new issues of safety or effectiveness are raised by the changes to the device discussed in this premarket notification.
The 3M™ Unitek™ Lava™ Chairside Oral Scanner will be manufactured by Brontes Technologies, Inc., a 3M Company, and distributed by 3M Unitek, another 3M Company,
Performance Standards
There are no changes to the performance standards with The 3M™ Unitek™ Lava™ Chairside Oral Scanner as compared to the predicate device. The 3M™ ESPE Lava™ Chairside Oral Scanner meets the following Performance Standards:
- . Tripartite Guidance - 1987 (G87-1)
- . Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA
1
- . ISO/EN 10993-1; 1997 Biological Evaluation of Medical Devices, Part I: Evaluation and Testing
- ISO/EN 10993-5; 1999 Tests for In-Vitro Cytotoxicity, 20d Ed �
- ISO/EN 10993-10; 2002 Tests for Irritation and Delayed Type . Hypersensitivity, 2nd Ed
- IEC 60601-1 Medical Electrical Equipment Part 1: General . Requirements for Safety
- IEC 60601-1-2 Medical Electrical Equipment Part 1 General . Requirements for Safety; Electromagnetic Compatibility -Requirements and Tests
- IEC 60601-1-4 medical Electrical Equipment Part 1 Medical . Electrical Equipment part 1-4: General Requirements for Collateral Standard: Programmable Electrical Medical Systems
- FDA Guidance on Dental Handpieces (Draft) July 1995 .
- . ISO 7405 - Pre-Clinical evaluation of Biocompatibility of medical devices used in dentistry, test methods for dental materials.
- FDA; Guidance for the Content of Pre-market Submissions for . Software Contained in Medical Devices - May 2005
- FDA Guidance; Cyber Security for Networked Medical Devices . Containing Off the Shelf Software
- ISO 14971 Medical devices Risk management Part 1: Application . of risk analysis
Conclusion:
There are more similarities than differences between the predicate devices and the 3M™ Unitek™ Lava™ Chairside Oral Scanner. The predicate device and the 3M™ Unitek™ Lava™ Chairside Oral Scanner have similar intended uses, warnings and contraindications. Both the 3M™ Unitek™ Lava™ Chairside Oral Scanner and predicate device may be used with a powder and powdering delivery system. When used in accordance with the instructions for use, by qualified personnel, the 3M™ Unitek™ Lava™ Chairside Oral Scanner is safe and effective, as indicated, for the intended use.
2
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Public Health Service
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Brontes Technologies, Incorporated C/o Mr. John Greenbaum President Generic Devices Consulting, Incorporated 20310 SW 48th Street Southwest Ranches, Florida 33332
Re: K081961
Trade/Device Name: 3M™ Unitek™ Lava™ Chairside Oral Scanner Regulation Number: 872.3661 Regulation Name: Optical Impression Systems for CAD/CAM Regulatory Class: II Product Code: NOF Dated: July 8, 2008 Received: July 9, 2008
SEP - 5 2008
Dear Mr. Greenbaum:
We have reviewed your Scotion 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Eederal Register.
3
Page 2 - Mr. Greenbaum
Please be advised that FDA's issuance of a substantial equivalcnce determination docs 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
J.W.amelis-Reed, m.y.
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): K081961
Device Name: 3M™ Unitek™ Lava™ Chairside Oral Scanner
Indications For Use:
The 3M™ Unitek™ Lava™ Chairside Oral Scanner is an optical impression system (CAD/CAM) used to record the topographical characteristics of teeth. Data generated from the 3M™ Unitek ™ Lava™ Chairside Oral Scanner may be used in conjunction with the production of orthodontic appliances, retainers and accessories.
Prescription Use X (Per 21 CRF 801.109) OR
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Turner
(Optional Format 1-2-96)
(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dantal Devices
510(k) Number: K081961