(349 days)
No
The summary describes a traditional ultrasonic scaler with no mention of AI or ML capabilities. The performance studies focus on electrical safety, EMC, and basic functional performance, not AI/ML performance metrics.
Yes.
The device's intended uses, such as removing calculus, scaling, root planing, and preparing root canals, are all therapeutic interventions aimed at treating dental conditions and restoring oral health.
No
The Intended Use / Indications for Use describes various dental procedures such as calculus removal, scaling, root planing, and preparing/cleaning root canals, which are therapeutic or interventional. The Device Description confirms its purpose is to remove plaque through ultrasonic vibration, a treatment function. There is no mention of diagnosing conditions, analyzing data to detect diseases, or assessing health states.
No
The device description explicitly states the product is provided in the form of parts that can be installed and used inside a dental chair and other dental devices, and it generates ultrasonic vibration through electricity and water supply, indicating it is a hardware device with integrated software for control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device's purpose is to remove plaque and perform various dental procedures directly on the tooth surface using ultrasonic vibration and water. It does not involve testing samples taken from the body.
- Intended Use: The listed intended uses are all related to dental procedures performed within the mouth, not laboratory testing of biological samples.
Therefore, this device falls under the category of a dental device used for treatment and procedures, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- removing supra and subgingival calculus and stains
- periodontal pocket lavage with simultaneous ultrasonic tip movement
- scaling and root planning
- releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- plugging for amalgam condensation
- amalgam burnishing
- preparing, cleanig, and irrigating root canals
- preparing approximal cavites
- cementing inlays and onlays
- retrograde preparation of root canals
Product codes
ELC
Device Description
The purpose of the device is to remove plaque from the surface of the tooth through using ultrasonic vibration generated by the electricity(24 V ~) and water supply received in a dental chair and other dental devices.
The product is provided in the form of parts that can be installed and used inside a dental chair and other dental devices. The control of the water supply is made from the dental chair and other dental devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical performance testing demonstrates that all design inputs for the Compact S is satisfied by the design outputs. Testing of the device, when integrated with a dental chair and handpiece was performed. Results of the integration testing showed that the device met electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) requirements. Additional integration testing included basic and essential performance as well as validation of the software in its actual use. Results from the functional and performance testing showed that the device met the predetermined acceptance criteria. The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed Compact S and the parent Clenase S+ lead to a conclusion of substantial equivalence between the proposed and predicate device.
The results of this testing confirm that the Compact S is as safe and effective as the predicate device for the intended use.
No clinical testing was conducted to support this submission.
Summary of non-clinical performance testing: all performance bench tests, sterilization and cleaning validations, biocompatibility, electrical and EMC and software.
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
Not Found
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 27, 2017
DMETEC Co., Ltd. % Yang Dong CEO Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-gil Gangnam-gu, Seoul 06253 KR
Re: K170104
Trade/Device Name: Compact S Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: November 22, 2017 Received: November 30, 2017
Dear Yang Dong:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170104
Device Name COMPACT S, COMPACT S(LED)
Indications for Use (Describe)
- removing supra and subgingival calculus and stains
- periodontal pocket lavage with simultaneous ultrasonic tip movement
- scaling and root planning
- releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- plugging for amalgam condensation
- amalgam burnishing
- preparing, cleanig, and irrigating root canals
- preparing approximal cavites
- cementing inlays and onlays
- retrograde preparation of root canals
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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.
| Submitter Information: | DMETEC Co., Ltd. |
|---|---|
| 402-601,602,603 bucheon techno-park, | |
| 655 pyeongcheon-ro, wonmi-gu | |
| Bucheon-city gyeonggi-do, KOREA, REPUBLIC OF 420-734 |
| Contact Person: Ho Dong, Yang | |
|---|---|
| Onbix Corporation | |
| #821 Samil Plaza, 14, Dogok-ro 1-gil, Gangnam-gu | |
| Seoul, Korea (06253) | |
| Tel: *82-2-566-3360 / Fax: *82-2-6280-3360 | |
| Email: onbix@naver.com |
Date Summary Prepared: Dec 27, 2017
Device Information:
Trade Name(s): Classification Name: Panel: Product Code & Requlation: COMPACT S. COMPACT S(LED) SCALER, ULTRASONIC
dental ELC / 872.4850
Predicate Device Information:
K060171 / CLEANSE S+ ULTRASONIC SCALER / DMETEC Co., Ltd.
Device Description:
The purpose of the device is to remove plaque from the surface of the tooth through using ultrasonic vibration generated by the electricity(24 V ~) and water supply received in a dental chair and other dental devices.
The product is provided in the form of parts that can be installed and used inside a dental chair and other dental devices. The control of the water supply is made from the dental chair and other dental devices.
Indications for Use:
- removing supra and subgingival calculus and stains
- periodontal pocket lavage with simultaneous ultrasonic tip movement
- scaling and root planning
- releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- plugging for amalgam condensation
- amalgam burnishing
- preparing, cleanig, and irrigating root canals
- preparing approximal cavites
- cementing inlays and onlays
- retrograde preparation of root canals
4
Summary of the technological characteristics compared to the predicate device
The proposed Compact S is virtually identical to the previously approved CLEANSE S + (ULTRASONIC SCALER, K060171).
Compact S is a model of drive module with the exterior case, power control keypad, and control device removed from the body of the previously approved product (CLEANSE S +), and can be installed to the dental chair.
The difference between the input powers of the two devices is that the previously approved product uses an adapter, and the proposed product is in a different form, powered by the dental chair.
The output current is also lowered from 40 VA to 24 VA due to structural changes due to the removal of the control keypad. However, the output of the handpiece is similar for both devices.
The difference between the two devices does not affect their safety or performance.
The device was conducted in compliance with the following Standard
- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) : Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2007 (Third Edition) : Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
- IEC 80601-2-60: 2012 (First Edition) : Medical electrical equipment: Part 2: Particular requirements for basic safety and essential performance of dental equipment
| | DMETEC
(COMPACT S) | DMETEC
(Cleanse S+) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
reference | Proposed | K060171 |
| Indication for
use | - removing supra and subgingival
calculus and stains
- periodontal pocket lavage with
simultaneous ultrasonic tip movement - scaling and root planning
- releasing crowns, bridges, inlays and
posts as well as condensing gutta
percha - plugging for amalgam condensation
- amalgam burnishing
- preparing, cleanig, and irrigating root
canals - preparing approximal cavites
- cementing inlays and onlays
- retrograde preparation of root canals | - removing supra and subgingival
calculus and stains - periodontal pocket lavage with
simultaneous ultrasonic tip
movement - scaling and root planning
- releasing crowns, bridges,
inlays and posts as well as
condensing gutta percha - plugging for amalgam
condensation - amalgam burnishing
- preparing, cleanig, and irrigating
root canals - preparing approximal cavites
- cementing inlays and onlays
- retrograde preparation of root
canals |
| Supply
voltage | AC/DC 24 V, 50/60 Hz | Transformer input : 100-240 V
AC , 50/60 Hz
Transformer output : DC 24V |
| Water supply
pressure | 1 to 5 bar (15 to 72 psi) | 1 to 5 bar (15 to 72 psi) |
| Maximum
output power
with load | 24VA | 40VA |
Comparison table is as follows
5
| Frequency range available | 24-32 kHz | 24-32 kHz | ||||||
|---|---|---|---|---|---|---|---|---|
| mode | Continuous | Continuous | ||||||
| Connection to second scaler unit | Not allowed | Not allowed | ||||||
| Main component | • Unit Body : 1ea | |||||||
| • Hand-piece : 1ea | ||||||||
| (Normal type or LED type) | ||||||||
| • Tip(Basic) : 3ea | ||||||||
| • Tip(option) : 2ea | • Unit Body : 1ea | |||||||
| • Hand-piece : 1ea(Normal type) | ||||||||
| • Tips(Basic) : 3ea | ||||||||
| • Tip(option) : 2ea | ||||||||
| * Compact S is a model of drive module with the exterior case, power control keypad, and control device removed from the body of the previously approved product (CLEANSE S +), and can be installed to the dental chair. | ||||||||
| *The COMPACT S and Cleanse S + use the same handpiece made from the same material. | ||||||||
| COMPACT S&COMPACT S LED | Cleanse S+ | |||||||
| 1 | Vibrator | Titanium+SU S | 1 | Vibrator | Titanium+SU S | |||
| 2 | Outsider cap | PPSU/25mm | ||||||
| 80-170 | 2 | Outsider cap | PPSU/25mm | |||||
| 80-170 | ||||||||
| Outsider cap | ||||||||
| (LED Type) | $17.6Φ*23.7m$ | |||||||
| m | ||||||||
| 3 | H.P BODY | PPSU/68mm | ||||||
| 140-170 | 3 | H.P BODY | PPSU/68mm | |||||
| 140-170 | ||||||||
| H.P BODY | ||||||||
| (LED Type) | PPSU/70mm | |||||||
| $18.5Φ$ - $17.5Φ$ | ||||||||
| 4 | HP Socket | |||||||
| (Upper) | PPSU/12.5m | |||||||
| m 150 | 4 | HP Socket | ||||||
| (Upper) | PPSU/12.5m | |||||||
| m 150 | ||||||||
| 5 | HP socket | |||||||
| (down) | PPSU/15mm | |||||||
| 11.50 | 5 | HP socket | ||||||
| (down) | PPSU/15mm | |||||||
| 11.50 | ||||||||
| 6 | Handpiece C | PPSU/19mm | ||||||
| 8 | 6 | Handpiece C | PPSU/19mm | |||||
| 8 | ||||||||
| 7 | O-ring 3 $Φ$ | |||||||
| 1.8T | Rubber/006 | 7 | O-ring 3 $Φ$ | |||||
| 1.8T | Rubber/006 | |||||||
| 8 | Vibrator O-ring down | 10 $Ø$ *1mm | 8 | Vibrator O-ring down | 10 $Ø$ *1mm | |||
| 9 | Handpiece socket O-ring Upper | Rubber/S11 | 9 | Handpiece socket O-ring Upper | Rubber/S11 | |||
| 10 | Water pin O-ring1 $Φ$ 1T | Rubber/P2 | 10 | Water pin O-ring1 $Φ$ 1T | Rubber/P2 | |||
| 11 | Terminal pin female | 4*21.8mm | 11 | Terminal pin female | 4*21.8mm | |||
| 12 | Water pin | inside1 $Ø$ | ||||||
| 4*21mm | 12 | Water pin | inside1 $Ø$ 4*2 | |||||
| 1mm | ||||||||
| 13 | LED Module | |||||||
| (LED Type) | $Ø$ 15.2*18.5m | |||||||
| m | - | |||||||
| *The difference between the two types of handpieces is the presence or absence of LEDs illuminating the mouth. |
6
| Tip material
(contact with
patient) | Stainless steel(SUS420J2) ※ The COMPACT S and Cleanse S + use the same shaped tip for the same
material. | Stainless steel(SUS420J2) |
| ------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------- | --------------------------- |
|---|
Summary of Non-Clinical performance testing as basis for substantial equivalence
Non-clinical performance testing demonstrates that all design inputs for the Compact S is satisfied by the design outputs. Testing of the device, when integrated with a dental chair and handpiece was performed. Results of the integration testing showed that the device met electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) requirements. Additional integration testing included basic and essential performance as well as validation of the software in its actual use. Results from the functional and performance testing showed that the device met the predetermined acceptance criteria. The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed Compact S and the parent Clenase S+ lead to a conclusion of substantial equivalence between the proposed and predicate device.
The results of this testing confirm that the Compact S is as safe and effective as the predicate device for the intended use.
Summary of clinical test as basis for substantial equivalence.
No clinical testing was conducted to support this submission.
Summary of non-clinical performance testing
all performance bench tests, sterilization and cleaning validations, biocompatibility, electrical and EMC and software.
The device was conducted in compliance with the following Standard
- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) : Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: 2007 (Third Edition) : Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
- IEC 80601-2-60: 2012 (First Edition) : Medical electrical equipment: Part 2: Particular requirements for basic safety and essential performance of dental equipment
- · ISO 17665-1/2 Sterilization of health care products
- · IEC 62304: 2006 : Medical device software Software life-cycle processes
- ISO 10993-1: 2009 : Biological evaluation of medical devices biocompatibility
Conclusion drawn from non-clinical and clinical tests
The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed COMPACT S and the Cleanse S+ lead to a conclusion of substantial equivalence between the proposed and predicate device