(365 days)
Not Found
No
The device description focuses on mechanical and electrical principles (ultrasonic waves, piezoelectric ceramic, air pressure) and does not mention any computational or learning components. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for use in dental (gum) therapy, polishing, and various dental treatments like scaling, root canal preparation, restorative work, and periodontal treatments, all of which are therapeutic interventions.
No
This device is used for dental treatments such as scaling, polishing, and root canal preparation, which are therapeutic and restorative procedures, not diagnostic ones. It performs actions on the teeth and gums rather than identifying or assessing conditions.
No
The device description clearly outlines multiple hardware components including a control module, display panel, water bottle, powder tank, handpieces, tips, nozzles, foot pedal, and power adapter. It also describes the physical mechanisms of action (ultrasonic vibrations and air pressure).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's teeth and gums (scaling, polishing, root canal work, restorative procedures, periodontal treatments). These are all in vivo procedures, meaning they are performed within the living body.
- Device Description: The device description details the mechanical and ultrasonic actions of the device to physically remove material from the teeth and perform other dental procedures. It does not describe any components or processes for analyzing samples of human origin (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis.
Therefore, the dental scaler and air polisher, Model PT-A, is a medical device used for direct treatment and procedures on the patient, not an IVD.
N/A
Intended Use / Indications for Use
The dental scaler and air polisher, Model PT-A, is intended for use in dental (gum) therapy and polishing. The device polishes the teeth and removes calculus deposits and stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. By attaching the ultrasonic handpiece with different scaling tips, the device could fulfill the following functions: 1 Scaling Removal of supragingival calculus; Removal of stains 2 Endo Preparation, cleaning and irrigation of root canals: Retrograde preparation of root canals Condensing gutta-percha; Removal of crown, bridges and restorations 3 Restorative - Cavity preparation; Luting inlays and onlays; Condensing of amalgams 4 Perio Scaling and root planing; Periodontal treatments By using air polishing handpiece attached with corresponding nozzles, the device could fulfill the following functions - · Removing dental plaque - · Surface preparation before bonding/cementation of inlays, crowns and veneers - · Tooth surface preparation before placing the composite restoration - · Cleaning before sticking orthodontic brackets - · Effectively removing plaque for orthodontic patients - · Cleaning the implant fixture before loading - · Stain removal for shade determination - · Removing plaque before fluoride treatment - · Removing plaque before whitening procedure
Product codes (comma separated list FDA assigned to the subject device)
ELC, KOJ
Device Description
The dental scaler and air polisher, Model PT-A, mainly consists of ultrasound scaler system and air polishing system. More specifically, it mainly contains a control module, a display panel with function keys, water bottle, powder tank, scaling handpiece, air polishing handpiece, scaling tips, sand blasting nozzle, foot pedal and power adapter. The device generates ultrasonic waves intended for dental applications such as scaling, root canal irrigation and periodontal preparation. For the ultrasonic system, a sinusoidal electrical signal is generated and delivered to the 'piezoelectric ceramic' located inside the ultrasonic handpiece. The electrical signal is converted into mechanical vibrations and propagated to the distal end of the handpiece. For air polishing system, the powder tank is driven by air pressure to flow into the nozzle attached with the air polishing handpiece and mixed with air and water to blast the teeth. By attaching the ultrasonic handpiece with appropriate scaling tips, the device could fulfill scaling, restorative, endodontal treatment. However, by attaching the corresponding nozzle to the air polishing handpiece, the device could remove calculus, stains, plaques and polish the teeth. The device is powered by a power adapter with input of 110V~ 50Hz/60Hz 800mA and output of 25V~ 50Hz/60Hz 2.8A. The ultrasonic handpiece, air polishing handpiece with or without non-disposal stainless steel sand blasting nozzles, and scaling tip are provided non-sterile, which will be sterilized by the user before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth and soft tissues in the mouth
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 testing was performed. Performance comparison test involves two standards: ISO 18397: 2016 Dentistry - Powered scaler and IEC 61205: 1993 Ultrasonics - Dental descaler systems - Measurement and declaration of the output characteristics. Performance comparison test performed on subject device and predicate device aims to support the substantial equivalence of the subject device to the predicate device. Test's setup and execution was in accordance with applicable standards. Results of the testing demonstrate the compliance to the standards and comparable performance between subject device and predicate device. Clinical testing was not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
December 10, 2021
Guilin Woodpecker Medical Instrument Co., Ltd. % Sonya Lai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518000 China
Re: K203615
Trade/Device Name: Dental scaler and air polisher Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC, KOJ Dated: November 11, 2021 Received: November 22, 2021
Dear Sonya Lai:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203615
Device Name Dental Scaler and Air Polisher
| Indications for Use (Describe) | |
|---|---|
| ---------------------------------------------- | -- |
The dental scaler and air polisher, Model PT-A, is intended for use in dental (gum) therapy and polishing. The device polishes the teeth and removes calculus deposits and stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. By attaching the ultrasonic handpiece with different scaling tips, the device could fulfill the following functions: 1 Scaling Removal of supragingival calculus; Removal of stains
2 Endo
Preparation, cleaning and irrigation of root canals: Retrograde preparation of root canals
Condensing gutta-percha; Removal of crown, bridges and restorations
3 Restorative
- Cavity preparation; Luting inlays and onlays; Condensing of amalgams
4 Perio
Scaling and root planing; Periodontal treatments
By using air polishing handpiece attached with corresponding nozzles, the device could fulfill the following functions
- · Removing dental plaque
- · Surface preparation before bonding/cementation of inlays, crowns and veneers
- · Tooth surface preparation before placing the composite restoration
- · Cleaning before sticking orthodontic brackets
- · Effectively removing plaque for orthodontic patients
- · Cleaning the implant fixture before loading
- · Stain removal for shade determination
- · Removing plaque before fluoride treatment
- · Removing plaque before whitening procedure
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
Product: Dental Scaler and Air Polisher
Version: A/0
510(k) Summary
1. Contact Details
1.1 Applicant information
| Applicant Name | Guilin Woodpecker Medical Instrument Co., Ltd. |
|---|---|
| Address | Information Industrial Park, Guilin National High-Tech Zone, Guilin, |
| Guangxi, 541004, P.R. China | |
| Phone No. | +86 773 2350532 |
| Contact person | Yiwei Wang |
| Date Prepared | Nov 15, 2021 |
| Website | http://www.glzmn.com/ |
- 1.2 Submission Correspondent
| Image: Logo
| 卓远天成 | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, | |
| Xili Town, Nanshan District, Shenzhen, Guangdong, 518000, China | |
| Phone No. | |
| Contact person | Sonya Lai; Field Fu |
| Contact person's e-mail | sonya@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
Device information 2.
.
| Trade name | Dental Scaler and Air Polisher |
|---|---|
| Common name | Ultrasonic scaler |
| Model | / |
| Classification | II |
| Classification name | Scaler, ultrasonic |
| Product code | ELC; KOJ |
| Regulation No. | 872.4850 |
Legally Marketed Predicate Device 3.
| Trade Name | EMS AIR-FLOW MASTER PLEZON
(Primary Predicate) |
|---------------|---------------------------------------------------|
| 510(k) Number | K110173 |
| Product Code | ELC; EFB; EJR |
| Manufacturer | E.M.S. Electro Medical Systems SA |
4. Device Description
The dental scaler and air polisher, Model PT-A, mainly consists of ultrasound scaler system and air polishing system. More specifically, it mainly contains a control module, a display panel with function
5
keys, water bottle, powder tank, scaling handpiece, air polishing handpiece, scaling tips, sand blasting nozzle, foot pedal and power adapter.
The device generates ultrasonic waves intended for dental applications such as scaling, root canal irrigation and periodontal preparation. For the ultrasonic system, a sinusoidal electrical signal is generated and delivered to the 'piezoelectric ceramic' located inside the ultrasonic handpiece. The electrical signal is converted into mechanical vibrations and propagated to the distal end of the handpiece. For air polishing system, the powder tank is driven by air pressure to flow into the nozzle attached with the air polishing handpiece and mixed with air and water to blast the teeth. By attaching the ultrasonic handpiece with appropriate scaling tips, the device could fulfill scaling, restorative, endodontal treatment. However, by attaching the corresponding nozzle to the air polishing handpiece, the device could remove calculus, stains, plaques and polish the teeth.
The device is powered by a power adapter with input of 110V~ 50Hz/60Hz 800mA and output of 25V~ 50Hz/60Hz 2.8A. The ultrasonic handpiece, air polishing handpiece with or without non-disposal stainless steel sand blasting nozzles, and scaling tip are provided non-sterile, which will be sterilized by the user before use.
5. Intended Use/Indication for Use
The dental scaler and air polisher, Model PT-A, is intended for use in dental cleaning, periodontal (gum) therapy and polishing. The device polishes the teeth and removes calculus deposits and stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.
By attaching the ultrasonic handpiece with different scaling tips, the device could fulfill the following functions:
- 1 Scaling
- · Removal of supragingival calculus
- · Removal of stains
-
- Endo
- · Preparation, cleaning and irrigation of root canals
- · Retrograde preparation of root canals
- · Condensing gutta-percha
- · Removal of crown, bridges and restorations
-
- Restorative
- · Cavity preparation
- · Luting inlays and onlays
- · Condensing of amalgams
- 4 Perio
- · Scaling and root planing
- · Periodontal treatments
However, by using air polishing handpiece attached with corresponding nozzles, the device could fulfill the following functions:
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Product: Dental Scaler and Air Polisher
Version: A/0
- Removing dental plaque
- · Surface preparation before bonding/cementation of inlays, crowns and veneers
- · Tooth surface preparation before placing the composite restoration
- Cleaning before sticking orthodontic brackets
- Effectively removing plaque for orthodontic patients
- · Cleaning the implant fixture before loading
- Stain removal for shade determination
- Removing plaque before fluoride treatment
- · Removing plaque before whitening procedure
Substantial Equivalence Comparison 6.
| Item | Proposed Device:
Dental Scaler and Air Polisher
(K203615) | Predicate Device:
EMS AIR-FLOW MASTER
PLEZON
(K110173) | Variations |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | ELC | ELC | Same |
| Subsequent
Product Code | KOJ | EFB, EJR | Same |
| Regulation
number | 872.4850 | 872.4850 | Same |
| Regulation
Generic Name | Ultrasonic scaler | Ultrasonic scaler | Same |
| Intended
Use/indication
for use | The dental scaler and air
polisher, Model PT-A, is intended
for use in dental cleaning,
periodontal (gum) therapy and
polishing. The device polishes
the teeth and removes calculus
deposits and stains from pits,
grooves, interproximal spaces, or
smooth surfaces of teeth. | The AIR-FLOW MASTER
PIEZON combines the functions
of an ultrasonic scaler and
air-polishing unit within a single
chassis. The AIR-FLOW
MASTER PIEZON is intended for
use in the following dental and
periodontal applications:
" Removing supra and
subgingival calculus deposits and
stains from teeth
- Periodontal pocket lavage with
simultaneous ultrasonic tip
movement - Scaling and root planing
- Releasing crowns, bridges,
inlays, and posts as well as
condensing gutta percha - Plugging for amalgam
condensation
"Amalgam burnishing | Same |
| | By attaching the ultrasonic
handpiece with different scaling
tips, the device could fulfill the
following functions:
*Scaling: Removal of
supragingival calculus; Removal
of stains
*Endo: Preparation, cleaning and
irrigation of root canals;
Retrograde preparation of root | | |
| Item | Proposed Device:
Dental Scaler and Air Polisher
(K203615) | Predicate Device:
EMS AIR-FLOW MASTER
PLEZON
(K110173) | Variations |
| | canals; Condensing gutta percha;
Removal of crown, bridges and
restorations | * Preparing, cleaning and
irrigating root canals | |
| | *Restorative: Cavity preparation;
Luting inlays and onlays;
Condensing of amalgams | * Cavity preparation
- Cementing inlays and onlays
- Retrograde preparation of root
canals;
The AIR-FLOW MASTER
PIEZON is intended for use in the
cleaning and polishing of teeth by
the projection of water, air, and
dental powders onto the tooth
surface. The device removes
dental plaque, soft deposits, and
surface stains from pits, grooves,
interproximal spaces, or smooth
surfaces of teeth. | |
| | *Perio: Scaling and root planing;
Periodontal treatments; | The AIR-FLOW MASTER
PIEZON can be used for the
following cleaning procedures: | |
| | However, by using air polishing
handpiece attached with
corresponding nozzles, the
device could fulfill the following
functions: Removing dental
plaque; Surface preparation
before bonding/cementation of
inlays, onlays, crowns and
veneers; Tooth surface
preparation before placing the
composite restoration; Cleaning
before sticking orthodontic
brackets; Effectively removing
plaque for orthodontic patients;
Cleaning the implant fixture
before loading; Stain removal for
shade determination; Removing
plaque before fluoride treatment;
Removing plaque before
whitening procedure | * Plaque removal for placement
of sealants - Surface preparation prior to
bonding/cementation of inlays,
onlays, crowns and veneers - Surface preparation prior to
placing composite restorations - Effective plaque and stain
removal for orthodontic patients - Cleaning prior to bonding ortho
brackets - Cleaning implant fixture prior to
loading - Stain removal for shade
determination - Plaque removal prior to fluoride
treatment - Plaque and stain removal prior
to whitening procedure; | |
| Item | Proposed Device:
Dental Scaler and Air Polisher
(K203615) | Predicate Device:
EMS AIR-FLOW MASTER
PLEZON
(K110173)
PLEZON is also intended for use
as an air-polisher in patients
suffering from periodontal
disease. The AIR-FLOW
MASTER PIEZON is indicated | Variations |
| | | for the non-surgical removal of
subgingival plaque in pockets up
to 5 mm after initial periodontal
treatment. | |
| Function | ultrasonic scaling and air
polishing | ultrasonic scaling and air
polishing | Same |
| Mechanism of
action | • Ultrasonic energy
• Projection of
water/air/powder mixture | • Ultrasonic energy
• Projection of
water/air/powder mixture | Same |
| Anatomical site | Teeth and soft tissues in the
mouth | Teeth and soft tissues in the
mouth | Same |
| Treatment site | Subgingival and supragingival | Subgingival and supragingival | Same |
| Components | • Control Unit
• Powder tank
• Water bottle
• Foot pedal
• Ultrasonic
Handpiece
• Air polishing Handpiece
(AP-1, AP-2) | • Control Unit
• Powder
chamber
• Irrigation liquid
bottle
• Foot pedal
• Piezon Handpiece
• LED
• AIR-FLOW Handpiece
• PERIO-FLOW
Handpiece | Equivalent |
| Contact
duration | Limited ≤ 24 hours | Limited ≤ 24 hours | Same |
| Operating
Mode | Continuous Operation | Continuous Operation | Same |
| Electric power
supply | • 110 VAC
• 50-60Hz | • 100-240 VAC
• 50-60Hz | Similar#1 |
| Ultrasound
Max output | 8W | 8W | Same |
7
8
Version: A/0
9
Version: A/0
| Item | Proposed Device:
Dental Scaler and Air Polisher
(K203615) | Predicate Device:
EMS AIR-FLOW MASTER
PLEZON
(K110173) | Variations |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------|
| Ultrasound
Frequency | $30 \pm 5$ kHz | 24 to 32 kHz | Similar#2 |
| Flow rate
adjustment | Touch panel | Touch panel | Same |
| Water delivery
system | One irrigating liquid bottle for ultrasonic scaling treatment and air polishing Connection to external water supply for both ultrasonic scaling and air-polishing treatment | One irrigating liquid bottle for ultrasonic scaling treatment Connection to external water supply for air polishing treatment | Similar#3 |
| Foot pedal | Wired, 4 functions | Wired, 4 functions | Same |
| Software | Yes | Yes | Equivalent |
| Biocompatibility | Biocompatible | Biocompatible | Same |
| Sterility | scaling tips, nozzles and
handpieces are resterilized to
reuse | scaling tips, nozzles and
handpieces are resterilized to
reuse | Same |
| Shelf life | Unrestricted | Unrestricted | Same |
The subject device and the predicate device have a slight difference in the following aspects. We discuss below to make it clear that these minor differences are not issues/concerns for the equivalency of the subject device and predicate device and don't affect the performance of safety and effectiveness of the subject device.
Similar #1 Electric power supply: the predicate device is supplied with power of 110vac, 50-60Hz while the subject device is supplied with 100-240Vac, 50-60Hz. This power difference is for the device to be compatible with different power supply system located in different areas/countries. The difference should not affect the device's performance of safety and efficacy.
Similar#2 Ultrasound frequency: the predicate device has an ultrasound frequency of 30±5kHz compared to the 24 to 32 kHz of predicate device. The ultrasound frequency of subject device varies from 25kHz to 35kHz, which falls within the range or almost the same as predicate device. Plus the subject device passed related requirements for safety and efficacy. Thus this minor difference does not raise any new issues or concerns of safety or effectiveness.
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Similar#3 Water delivery system: the subject device has an irrigating water bottle for ultrasonic scaling treatment and air polishing. It also is connected to external water supply for both ultrasonic scaling and air polishing. As a comparison, the predicate device has an irrigating water bottle for ultrasonic scaling system and is connected to external water supply for air polishing treatment. Even though the subject device has one more choice of water sources for either scaling or polishing treatment than the predicate device, in both of the devices, the scaling system and the air polishing system are all provided with water in order for the device to work properly. The difference of water supply choice doesn't affect the subject device's performance of safety and efficacy.
7. Non-clinical Testing
The subject device conforms to the following standards:
IEC 60601-1:2005+CORR.1:2006+CORR.2007+A1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
IEC 60601-1-2:2014 Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances-Requirements And Tests
IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity. Biocompatibility testing of in vitro cytotoxicity was performed to verify the equivalent safety of the materials that are in direct contact with mucosal membrane and teeth in the mouth, and skin including ultrasonic handpiece, air polishing handpiece, scaling tips and sand blasting nozzle. The testing was also carried out for materials that are in indirect contact with the same sites including the device components/parts involved in contacting water or pressurized air. The testing results indicate the materials meet the requirements.
ISO 10993-10:2010 Biological Evaluation of Medical Devices- Part 10: Tests for Irritation and Skin Sensitization
Biocompatibility testing for Irritation and Skin Sensitization was performed to verify the equivalent safety of the materials that are in direct contact with mucosal membrane and teeth in the mouth, and skin including ultrasonic handpiece, air polishing handpiece, scaling tips and sand blasting nozzle. The testing was also carried out for materials that are in indirect contact with the same sites including the device components/parts involved in contacting water or pressurized air. The testing results indicate that the materials meet the requirements.
ISO 17665-1: 2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the
11
Product: Dental Scaler and Air Polisher
development, validation and routine control of a sterilization process for medical devices
Performance comparison test involves two standards: ISO 18397: 2016 Dentistry - Powered scaler and IEC 61205: 1993 Ultrasonics - Dental descaler systems - Measurement and declaration of the output characteristics.
Performance comparison test performed on subject device and predicate device aims to support the substantial equivalence of the subject device to the predicate device. Test's setup and execution was in accordance with applicable standards. Results of the testing demonstrate the compliance to the standards and comparable performance between subject device and predicate device.
8. Clinical testing
The substantial equivalence of the subject device to the predicate device doesn't depend on clinical testing, thus clinical testing was not performed for the proposed device.
9. Other information (such as required by FDA guidance/Test)
N/A
10. Conclusions Drawn from Non-Clinical and Clinical Tests
The Dental Scaler and Air Polisher is substantially equivalent to the legally marketed predicate EMS AIR-FLOW MASTER PIEZON (K110173).