(83 days)
No
The summary describes a device that applies electrical current to accelerate bleaching, with no mention of AI or ML in its function, description, or testing.
Yes
The device is described as improving the whitened appearance of teeth, and performance studies confirm it produced significantly greater improvement in tooth whitening than the control, indicating it provides a therapeutic benefit.
No
The device is intended for teeth bleaching to improve the whitened appearance of teeth, which is a cosmetic purpose, not a diagnostic one. It does not identify or characterize any medical condition or disease.
No
The device description clearly outlines physical hardware components including a mouth tray, battery, button, and electrical current delivery system, indicating it is not software-only.
Based on the provided information, the Tanda Pearl device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "for teeth bleaching" and to "improve the whitened appearance of teeth." This is a cosmetic or aesthetic purpose, not for diagnosing, monitoring, or treating a disease or condition based on in vitro examination of specimens derived from the human body.
- Mechanism of Action: The device uses low electrical current to accelerate the action of a bleaching agent applied to the teeth. This is a physical/chemical process applied directly to the body (teeth), not an analysis of a sample taken from the body.
- Device Description: The description focuses on the physical components (mouth tray, battery, button) and the delivery of electrical current. There is no mention of analyzing biological samples.
- Anatomical Site: The anatomical site is "teeth," which are part of the body, not a specimen derived from the body for in vitro analysis.
IVDs are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or treatment. The Tanda Pearl does not fit this description.
N/A
Intended Use / Indications for Use
The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda The Tanual I can is an over the occalities action of the bleaching agent to improve the whitened appearance of teeth.
Product codes
EEG
Device Description
The Tanda Pearl device consists of a double biting mouth tray made of silicone for I he faing both the upper and bottom teeth simultaneously. A bleaching agent is applied to each side of the mouth tray. The device is battery operated and turned on using a button located on the handle. Once initialized, the device delivers low amounts of electrical current (4 to 15 mA) into the bleaching medium to accelerate the teeth whitening effect caused by the bleaching medium. Once the treatment cycle has been completed, the device is automatically shut off.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter
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
In addition to the non-clinical data that supports the high degree of similarity between the Tanda Pearl and its predicates, the results of a single site IRB clinical study performed under the original technology developer, Fluorinex Active Ltd., further support a finding of substantial equivalence:
- The Tanda Pearl device produced significantly greater improvement in tooth . whitening than the control, as measured using both the Vita Shade scores and the Vita Shade Delta-E scores. Significant results were maintained through 6 months.
- With respect to safety, no significant safety concerns were noted and all reported . events associated with the Tanda Pearl device were rated as mild in severity and all were followed to resolution.
Key Metrics
Not Found
Predicate Device(s)
Dentovations Inc.'s South Beach Smile Light Whitening System (K042153), CAO Group Inc.'s SonX 35 Ultrasonic Bleaching System (K041392)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.6475 Heat source for bleaching teeth.
(a)
Identification. A heat source for bleaching teeth is an AC-powered device that consists of a light or an electric heater intended to apply heat to a tooth after it is treated with a bleaching agent.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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510(k) SUMMARY
Syneron Beauty Inc's Tanda Pearl
NOV 2 7 2012
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Syneron Beauty Inc.
11-380 Jamieson Parkway Cambridge, Ontario, Canada N3C 4N4
Phone: +1-519-651-1177 X 225 Facsimile: +1-519-651-2277
Contact Person: Omri Hayet- COO
Date Prepared: September 5, 2012
Name of Device
Tanda Pearl
Common or Usual Name
Heat source for bleaching teeth
Classification Name
EEG
Predicate Devices
Glo Science LLC's Glo Brilliant Whitening Device (510(k) exempt)
Dentovations Inc.'s South Beach Smile Light Whitening System (K042153)
CAO Group Inc.'s SonX 35 Ultrasonic Bleaching System (K041392)
Intended Use / Indications for Use
The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda The Tanual I can is an over the occalities action of the bleaching agent to improve the whitened appearance of teeth.
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Technological Characteristics
The Tanda Pearl device consists of a double biting mouth tray made of silicone for I he faing both the upper and bottom teeth simultaneously. A bleaching agent is applied to each side of the mouth tray. The device is battery operated and turned on using a button located on the handle. Once initialized, the device delivers low amounts of electrical current (4 to 15 mA) into the bleaching medium to accelerate the teeth whitening effect caused by the bleaching medium. Once the treatment cycle has been completed, the device is automatically shut off.
Performance Data
The following performance testing was conducted to support the substantial equivalence of the Tanda Pearl:
- electrical safety (IEC 60601-1: 2005) .
- electromagnetic compatibility testing (IEC 60601-1-2: 2007) .
- device integrity testing (packaging/transport) (ISTA 2 Series: Partial Simulation . Performance Tests- Procedure 2A)
- biocompatibility assessment (IEC 10993-1:2009) .
- software verification and validation testing and (IEC 62304: 2006) .
- risk analysis (ISO 14971: 2009) .
All of these tests confirmed that the Tanda Pearl performs as intended.
Clinical Performance Data
In addition to the non-clinical data that supports the high degree of similarity between the Tanda Pearl and its predicates, the results of a single site IRB clinical study performed under the original technology developer, Fluorinex Active Ltd., further support a finding of substantial equivalence:
The following key results of the study further support the efficacy and safety of the Tanda Pearl device:
- The Tanda Pearl device produced significantly greater improvement in tooth . whitening than the control, as measured using both the Vita Shade scores and the Vita Shade Delta-E scores. Significant results were maintained through 6 months.
- With respect to safety, no significant safety concerns were noted and all reported . events associated with the Tanda Pearl device were rated as mild in severity and all were followed to resolution.
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Substantial Equivalence
The Tanda Pearl is substantially equivalent to the Glo Science LLC's Glo Brilliant Whitening Device (510(k)-Exempt), Dentovations Inc.'s South Beach Smile Light Whitening System (K042153) and the CAO Group Inc.'s SonX 35 Ultrasonic Bleaching System (K041392).
The Tanda Pearl has similar intended use, similar technological characteristics, and principles of operation as its predicate devices. The technological differences between the Tanda Pearl and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that these minor differences do not adversely impact the safety of the device for its intended use. The Tanda Pearl is substantially equivalent.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Syneron Beauty, Incorporated C/O Janice M. Hogan, Esq. Partner Hogan Lovells US, Limited Liability Partnership 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
NOV 2 7 2012
Re: K122725
Trade/Device Name: Tanda Pearl Regulation Number: 21 CFR 872.6475 Regulation Name: Heat Source for Bleaching Teeth Regulatory Class: I Product Code: EEG Dated: November 16, 2012 Received: November 20, 2012
Dear Ms. Hogan:
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.
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Page 2 - Ms. Hogan
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 ------
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
5
Indications for Use Statement
510(k) Number (if known):
Device Name: Tanda Pearl
Indications for Use: The Tanda Pearl is an over-the-counter device intended for teeth bleaching. The Tanda Pearl uses low electrical current to accelerate the action of the bleaching agent to improve the whitened appearance of teeth.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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)
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Robert S. Betz 2012.11.21 12:13:21=05'00'
(Division Sign-Off) Division of Anestheslology, General Hospital Infection Control, Dental Devices
Page of
K 22.725 510(k) Number:_
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