(365 days)
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
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.
The provided text is a 510(k) summary for a dental scaler and air polisher. This type of regulatory document is typically focused on demonstrating "substantial equivalence" to a predicate device, rather than proving a device meets specific performance acceptance criteria through a detailed clinical study in the way a diagnostic AI device might.
Therefore, the document does not contain the kind of information requested in the prompt regarding acceptance criteria and performance studies for a diagnostic AI device. The device described (a dental scaler and air polisher) is a physical medical device, not a software or AI-driven diagnostic tool.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance: While there's a comparison table to a predicate, it focuses on features, intended use, and technical specifications, not specific quantifiable performance metrics with predefined acceptance thresholds.
- Sample size and data provenance (
test set): No test set of clinical data is described. - Number of experts and qualifications for ground truth (
test set): Not applicable as there's no diagnostic test set requiring expert ground truth. - Adjudication method (
test set): Not applicable. - Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned, as it's not relevant for this type of device submission.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
Instead, the document details physical and electrical specifications, biocompatibility, and sterilization validation, and compares these aspects to a predicate device to demonstrate substantial equivalence. The "Non-clinical Testing" section mentions adherence to various international standards (e.g., IEC 60601-1, ISO 10993-5, ISO 18397) to ensure safety and effectiveness, but these are general compliance requirements rather than specific performance acceptance criteria for a diagnostic algorithm. It also states that "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." However, the exact metrics and acceptance criteria for these performance comparisons are not detailed in this summary.
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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.
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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
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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.
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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
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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 MASTERPLEZON(K110173) | Variations |
|---|---|---|---|
| Product Code | ELC | ELC | Same |
| SubsequentProduct Code | KOJ | EFB, EJR | Same |
| Regulationnumber | 872.4850 | 872.4850 | Same |
| RegulationGeneric Name | Ultrasonic scaler | Ultrasonic scaler | Same |
| IntendedUse/indicationfor use | The dental scaler and airpolisher, Model PT-A, is intendedfor use in dental cleaning,periodontal (gum) therapy andpolishing. The device polishesthe teeth and removes calculusdeposits and stains from pits,grooves, interproximal spaces, orsmooth surfaces of teeth. | The AIR-FLOW MASTERPIEZON combines the functionsof an ultrasonic scaler andair-polishing unit within a singlechassis. The AIR-FLOWMASTER PIEZON is intended foruse in the following dental andperiodontal applications:" Removing supra andsubgingival calculus deposits andstains from teeth* Periodontal pocket lavage withsimultaneous ultrasonic tipmovement* Scaling and root planing* Releasing crowns, bridges,inlays, and posts as well ascondensing gutta percha* Plugging for amalgamcondensation"Amalgam burnishing | Same |
| By attaching the ultrasonichandpiece with different scalingtips, the device could fulfill thefollowing functions:*Scaling: Removal ofsupragingival calculus; Removalof stains*Endo: Preparation, cleaning andirrigation of root canals;Retrograde preparation of root | |||
| Item | Proposed Device:Dental Scaler and Air Polisher(K203615) | Predicate Device:EMS AIR-FLOW MASTERPLEZON(K110173) | Variations |
| canals; Condensing gutta percha;Removal of crown, bridges andrestorations | * Preparing, cleaning andirrigating root canals | ||
| *Restorative: Cavity preparation;Luting inlays and onlays;Condensing of amalgams | * Cavity preparation* Cementing inlays and onlays* Retrograde preparation of rootcanals;The AIR-FLOW MASTERPIEZON is intended for use in thecleaning and polishing of teeth bythe projection of water, air, anddental powders onto the toothsurface. The device removesdental plaque, soft deposits, andsurface stains from pits, grooves,interproximal spaces, or smoothsurfaces of teeth. | ||
| *Perio: Scaling and root planing;Periodontal treatments; | The AIR-FLOW MASTERPIEZON can be used for thefollowing cleaning procedures: | ||
| However, by using air polishinghandpiece attached withcorresponding nozzles, thedevice could fulfill the followingfunctions: Removing dentalplaque; Surface preparationbefore bonding/cementation ofinlays, onlays, crowns andveneers; Tooth surfacepreparation before placing thecomposite restoration; Cleaningbefore sticking orthodonticbrackets; Effectively removingplaque for orthodontic patients;Cleaning the implant fixturebefore loading; Stain removal forshade determination; Removingplaque before fluoride treatment;Removing plaque beforewhitening procedure | * Plaque removal for placementof sealants* Surface preparation prior tobonding/cementation of inlays,onlays, crowns and veneers* Surface preparation prior toplacing composite restorations* Effective plaque and stainremoval for orthodontic patients* Cleaning prior to bonding orthobrackets* Cleaning implant fixture prior toloading* Stain removal for shadedetermination* Plaque removal prior to fluoridetreatment* Plaque and stain removal priorto whitening procedure; | ||
| Item | Proposed Device:Dental Scaler and Air Polisher(K203615) | Predicate Device:EMS AIR-FLOW MASTERPLEZON(K110173)PLEZON is also intended for useas an air-polisher in patientssuffering from periodontaldisease. The AIR-FLOWMASTER PIEZON is indicated | Variations |
| for the non-surgical removal ofsubgingival plaque in pockets upto 5 mm after initial periodontaltreatment. | |||
| Function | ultrasonic scaling and airpolishing | ultrasonic scaling and airpolishing | Same |
| Mechanism ofaction | • Ultrasonic energy• Projection ofwater/air/powder mixture | • Ultrasonic energy• Projection ofwater/air/powder mixture | Same |
| Anatomical site | Teeth and soft tissues in themouth | Teeth and soft tissues in themouth | Same |
| Treatment site | Subgingival and supragingival | Subgingival and supragingival | Same |
| Components | • Control Unit• Powder tank• Water bottle• Foot pedal• UltrasonicHandpiece• Air polishing Handpiece(AP-1, AP-2) | • Control Unit• Powderchamber• Irrigation liquidbottle• Foot pedal• Piezon Handpiece• LED• AIR-FLOW Handpiece• PERIO-FLOWHandpiece | Equivalent |
| Contactduration | Limited ≤ 24 hours | Limited ≤ 24 hours | Same |
| OperatingMode | Continuous Operation | Continuous Operation | Same |
| Electric powersupply | • 110 VAC• 50-60Hz | • 100-240 VAC• 50-60Hz | Similar#1 |
| UltrasoundMax output | 8W | 8W | Same |
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Version: A/0
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Version: A/0
| Item | Proposed Device:Dental Scaler and Air Polisher(K203615) | Predicate Device:EMS AIR-FLOW MASTERPLEZON(K110173) | Variations |
|---|---|---|---|
| UltrasoundFrequency | $30 \pm 5$ kHz | 24 to 32 kHz | Similar#2 |
| Flow rateadjustment | Touch panel | Touch panel | Same |
| Water deliverysystem | 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 andhandpieces are resterilized toreuse | scaling tips, nozzles andhandpieces are resterilized toreuse | 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
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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).
§ 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.