The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgystar piezosurgery system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following intended uses:

Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
Soft tissue debridement and removal, particularly in intrabony lesions.

Device Description

The Contour P-Insert System (CPIS) is an accessory to the Dmetec Surgystar Piezosurgery System (DSPS). The CPIS comprises two sets of components. CPIS tips and CPIS shafts, as follows:

CPIS Shafts: The two CPIS shaft models (45 and 90) are machined from 431 stainless steel. Both models ● have an identical female threaded proximal end that is designed and configured to attach to the DSPS handpiece distal male threaded end. On the shafts' distal end, both models have an identical male threaded section that is designed and configured to attach the various models of CPIS tips. These models
45 and 90 differ primarily in that the CPIS 45 has a mid-shaft bend of 20.59 while the CPIS 90 does not.
CPIS Tips: The three CPIS tip models (Tri, WC and QT) are machined from PEEK ● (polyetheretherketone). All three tip models have an identical female unthreaded hole on the proximal end that is designed and configured to attach to the distal male threaded end of the CPIS shafts. These tips have different grooves, edges and vertices that abrade, ablate, cut and recontour oral tissues as intended by the operator.
CPIS Inserts: The CPIS inserts are created by the end user by attaching one CPIS tip to one CPIS shaft. By combining each of the three tip models with each of the two shafts models, six versions of CPIS insert can thus be created, depending on the clinical needs and professional judgement of the end-user. These resultant CPIS inserts are designated as follows: CPIS 45/WC, CPIS 45/QT, CPIS 90/Tri, CPIS 90/WC and CPIS 90/QT. The CPIS inserts are attached to the DSPS using the DSPS torque wrench.

During use by the end user, the DSPS is powered, generating high frequency mechanical micro-vibrations in the handpiece, that is transmitted to the CPIS insert. The tip sides and tip end of the CPIS inserts are brought into contact with the patient's various oral tissue types to accomplish dental procedures where ablation, abrasion, cutting and/or recontouring of the target tissue is desired.

AI/ML Overview

The provided text describes the Contour P-Insert System (CPIS), an accessory for dental piezo-surgery systems, and its substantial equivalence to predicate devices based on non-clinical testing. Here's a breakdown of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally qualitative, focusing on functionality, safety, and effectiveness in performing specific dental procedures. The reported performance likewise describes the successful fulfillment of these criteria.

Acceptance Criteria (Test Objective)	Reported Device Performance (Outcome & Conclusion)
Compatibility with DSPS torque wrench: Determine if the CPIS is compatible with the predicate device DSPS torque wrench accessory.	Outcome: The DSPS torque wrench fit, engaged, retained, and easily disengaged from 100% of the CPIS samples. Conclusion: Demonstrates compatibility and Substantial Equivalence due to consistent fit, critical for proper function.
Compatibility with DSPS handpiece: Determine if the CPIS shaft proximal female threaded connector is compatible with the predicate DSPS handpiece distal end male threaded connector.	Outcome: No loosening of the CPIS inserts from the DSPS handpiece was observed in 100% of samples. Conclusion: Demonstrates compatibility of CPIS with DSPS handpiece and Substantial Equivalence; CPIS fits securely.
Effectiveness for Soft Tissue Debridement & Periodontal Surgery: Determine if the CPIS is "as safe and effective" as the predicate in performing soft tissue debridement and periodontal surgery.	Outcome: For all samples in all groups, soft tissue was effectively debrided to expose all intended root surfaces. Conclusion: Demonstrates CPIS is "as safe and effective" as the predicate for these indications, thus Substantially Equivalent.
Effectiveness for Osteotomy, Osteoplasty & Periodontal Surgery: Determine if the CPIS is "as safe and effective" as the predicate in performing osteotomy, osteoplasty and periodontal surgery.	Outcome: For all samples in all groups, more than 1mm of bone, but less than 3mm of bone, was removed from around all Mock Resorptive Lesions as intended. Conclusion: Demonstrates CPIS is "as safe and effective" as the predicate for these indications, thus Substantially Equivalent.
Safety - Tooth Surface Damage: Determine if the CPIS PEEK tips and the DSPS inserts damage tooth surfaces.	Outcome: In all cases, the CPIS QT PEEK tip did not cause any discernible tooth surface damage, while both DSPS inserts caused extensive tooth surface damage. Conclusion: Demonstrates CPIS is safe for use when in contact with tooth structure and is superior to the predicate device DSPS inserts tested regarding tooth surface damage.
Biological Evaluation (PEEK material): Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, In Vitro Hemolytic Properties, Complement Activity.	Outcome: Results show the subject device (PEEK) is substantially equivalent to the predicate and reference devices in terms of biological safety standards (ISO10993 series).
Sterilization Validation: Moist Heat Sterilization process.	Outcome: Tests performed according to ISO17665, ISO14937, ISO11138-3, and ANSI/AAMI ST79. Conclusion: The CPIS can be effectively sterilized by steam. (Implicitly, the validation confirms ability to be rendered sterile safely and effectively).

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes for each specific test in the "CPIS Functionality and Efficacy Report" and "Tooth Surface Damage Study." It generally refers to "100% of the CPIS samples" for compatibility tests and "all samples in all groups" for efficacy tests. More precise numbers are not provided.

The provenance of this data (e.g., country of origin, retrospective or prospective) is not specified. However, the tests are described as non-clinical tests, implying they were likely conducted in a laboratory or controlled setting (e.g., using models, cadavers, or animal tissue as proxies for human tissue, though the document does not specify). There is no mention of human clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish a "ground truth" for these non-clinical tests in the way one might for diagnostic imaging or clinical studies. The "ground truth" for these tests appears to be based on direct observation of physical interactions (e.g., fit, loosening) and outcomes of mechanical actions (e.g., amount of bone removed, effectiveness of debridement, presence/absence of tooth surface damage) against predefined objective criteria. No independent expert review or adjudication of results against a gold standard established by experts is described.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1, none) is mentioned or implied for the non-clinical tests described. The "outcomes" are direct, measurable results of the tests (e.g., 100% fit, specific range of bone removal, discernible damage).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was conducted or mentioned. The device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a surgical accessory, not an algorithm. Its performance is always in the context of human operation.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical efficacy and safety tests is based on:

Direct observation of mechanical fit and interaction: For compatibility tests (torque wrench, handpiece connection).
Quantitative and qualitative measures of physical outcomes: For efficacy tests (e.g., "effectively debrided," "more than 1mm but less than 3mm of bone removed") and safety tests (e.g., "no discernible tooth surface damage," "extensive tooth surface damage").
Compliance with established biological safety standards: For biological evaluation (ISO10993 series).
Compliance with established sterilization standards: For sterilization validation (ISO standards).

These are essentially experimental outcomes from carefully designed non-clinical tests rather than "expert consensus," "pathology," or "outcomes data" in a clinical sense.

8. Sample Size for the Training Set

Not applicable. The Contour P-Insert System is a physical medical device (an accessory for a piezosurgery system), not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 9, 2020

Bennett Jacoby, DDS, MS, Inc. Bennett Jacoby President 77-6425 Kuakini Hwy, C2-84 Kailua Kona, Hawaii 96740

Re: K192033

Trade/Device Name: Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZI, ELC Dated: May 6, 2020 Received: May 11, 2020

Dear Bennett Jacoby:

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 medical devices and radiation-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.

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K192033

Device Name Contour P-Insert System (CPIS)

Indications for Use (Describe)

Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
Soft tissue debridement and removal, particularly in intrabony lesions.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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FORM FDA 3881 (7/17)

Page 1 of 1

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4. 510(k) SUMMARY

510(k) Sponsor & Manufacturer Information
510(k) Sponsor & Manufacturer	Bennett Jacoby, DDS, MS, Inc.
Address	77-6425 Kuakini Hwy, C2-84, Kailua-Kona, HI 96740
Telephone	731 451 0213
Email	bjacobyddsms@gmail.com
510(k) Summary Preparation Date	June 4 2020

510(k) Submitter Information
510(k) Submitter Name	Marc Sanchez
Company Name	Contract In-House Counsel & Consultants, LLC (d/b/a FDA Atty)
Telephone	202 765 4491
Email	msanchez@fdaatty.com

Device Information
Device Name	Contour P-Insert System
Classification Name	a) Drill, bone, poweredb) Scaler, ultrasonic
Product Code	DZI, ELC
Device Classification Panel	OHT1/DHT1B (Dental Devices)
Device Classification	Class II

Predicate Devices

Predicate Device Name	Predicate Device Sponsor	Product Code	510(k) No.
Surgystar	Predicate Device	Dmetec Co. Ltd.	DZI	K113152
Diamond CoatedInserts	Reference Device 1	DentsplyInternational	ELC	K030111
Piezosurgery Plus	Reference Device 2	Mectorn S.p.a.	JDX, DZI, ERL,HBE, HWE	K153743

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Device Description

The Contour P-Insert System (CPIS) is an accessory to the Dmetec Surgystar Piezosurgery System (DSPS). The CPIS comprises two sets of components. CPIS tips and CPIS shafts, as follows:

CPIS Shafts: The two CPIS shaft models (45 and 90) are machined from 431 stainless steel. Both models ● have an identical female threaded proximal end that is designed and configured to attach to the DSPS handpiece distal male threaded end. On the shafts' distal end, both models have an identical male threaded section that is designed and configured to attach the various models of CPIS tips. These models
45 and 90 differ primarily in that the CPIS 45 has a mid-shaft bend of 20.59 while the CPIS 90 does not.
CPIS Tips: The three CPIS tip models (Tri, WC and QT) are machined from PEEK ● (polyetheretherketone). All three tip models have an identical female unthreaded hole on the proximal end that is designed and configured to attach to the distal male threaded end of the CPIS shafts. These tips have different grooves, edges and vertices that abrade, ablate, cut and recontour oral tissues as intended by the operator.
CPIS Inserts: The CPIS inserts are created by the end user by attaching one CPIS tip to one CPIS shaft. By combining each of the three tip models with each of the two shafts models, six versions of CPIS insert can thus be created, depending on the clinical needs and professional judgement of the end-user. These resultant CPIS inserts are designated as follows: CPIS 45/WC, CPIS 45/QT, CPIS 90/Tri, CPIS 90/WC and CPIS 90/QT. The CPIS inserts are attached to the DSPS using the DSPS torque wrench.

Indications for Use

The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgesy system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following uses:

1. Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation.
1. Soft tissue debridement and removal, particularly in intrabony lesions.

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Technological Characteristics

Characteristic	Subject Device	PredicateDeviceK113152	Reference Device 1K030111	Reference Device2K153743
Device	Contour P-Insert System(CPIS)	Surgystar	Diamond Coated Inserts	Piezosurgery Plus
Indicationsfor Use	1) Surgical proceduresincluding osteotomy,osteoplasty, periodontalsurgery and implantation.2) Soft tissue debridementand removal, particularlyin intrabony lesions.	1) in surgicalproceduresincludingosteotomy,osteoplasty,periodontalsurgery andimplantation.	1) Removal of extremelytenacious deposits ofcalculus in both non-surgicaland surgically exposedcases.2) Removal of overhangs andre-contouring of dentalrestorations (amalgam, gold,composite, acrylic andporcelain) in both non-surgicaland surgically exposed cases.3) Soft tissue debridement -removal of tissue tags,particularly in intrabonylesions	1) Ultrasonicsurgical systemconsisting ofhandpieces andassociated tipsfor osteotomy,osteoplasty anddrilling in avariety of surgicalprocedures
Compatibility &Functionality	The user assembled CPISinserts are attached to themale thread on the distal endof the Dmetec handpiece.	The DSPSinserts areattached themale thread onthe distal end ofthe Surgystarhandpiece	NA - compatibility andfunctionality of the CPISrequired with Predicate Deviceonly	NA - compatibilityand functionalityof the CPISrequired withPredicate Deviceonly

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Characteristic	Subject Device	Predicate DeviceK113152	Reference Device 1K030111	Reference Device 2K153743
Design	Insert:End-User assembledCPIS Inserts are createdfrom one shaft and one tip.Two CPIS Shaft Designs:Rigid 431 stainless steelshaft-like piece with adistal segment angulationof 69.5 degrees (Model 45)or 90 degrees (Model 90)in relation to the long axisof the shaft.Three CPIS Tip Designs:Triangular, non-steppedpyramid (Model Tri)Stepped cone (ModelWC) Four-sided steppedpyramid (Model QT)	The DSPS insertsdo not havecomponents - theyare a single unit.DSPS metal insertwith a saw-tootheddistal working endwith 3 sharp points.DSPS insert with aball shaped distalworking end thatis coated indiamond grit.	The Diamond Coatedinserts do not havecomponents - theyare a single unit.This is anindustry-typicalmagnetostrictivescaler insert with anarch-shapedworking end withthe terminal distalend coated withdiamond grit.	Metal insertsdesigned andconfigured to cutand drill bone.
SterilizationState	Supplied non-sterile	Supplied non-sterile	Supplied non-sterile	Supplied sterile
SterilizationMethod (priorto use)	Steam Sterilization	Steam sterilization	Steam sterilization	EO sterilization
InsertMaterials	Shaft:431 Stainless SteelTipPEEK	Stainless Steel ofunspecified type	Diamond & Nickel(known materials)	InsertTitanium alloy,316/316L stainlesssteel,Protective SleevePEEK

Non-Clinical Test Reports - Applicable Standards

The following tests were performed on the Contour P-Insert System and the test results show that the subject device is substantially equivalent to the predicate and reference devices:

Test Name	Standard
In Vitro Cytotoxicity Test of PEEK	ISO10993-5:2009 (Biological evaluation of medical devices— Part 5: Tests for in vitro cytotoxicity)
Skin Sensitization Test of PEEK	ISO10993-10:2010 (Biological evaluation of medicaldevices — Part 10: Tests for skin sensitization)
Intracutaneous Reactivity Test of PEEK	ISO10993-10:2010 (Biological evaluation of medicaldevices — Part 10: Tests for skin sensitization)
Acute Systemic Toxicity of PEEK	ISO10993-11:2017 (Biological evaluation of medicaldevices — Part 11: Tests for systemic toxicity)
Pyrogen Test of PEEK	ISO10993-11:2017 (Biological evaluation of medicaldevices — Part 11: Tests for systemic toxicity)
In Vitro Hemolytic Properties Test of PEEK	ISO10993-4:2017 (Biological evaluation of medical devices— Part 4: Selection of tests for interactions with blood)
Complement Activity (C3a,SC5b-9) Test ofPEEK	ISO10993-4:2017 (Biological evaluation of medical devices— Part 4: Selection of tests for interactions with blood)
Sterilization Validation (including dryingvalidation)	ISO17665 - 1:2006 / (R)2013 (Sterilization of healthcareproducts — Moist Heat — Part 1 Requirements for thedevelopment, validation and routine control of a sterilizationprocess for medical devices)
	ISO14937:2009 / (R)2013 (Sterilization of health careproducts — General requirements for characterization of asterilizing agent and the development, validation androutine control of a sterilization process for medicaldevices)
	ISO11138-3:2017 (Sterilization of health care products —Biological indicators – Part 3: Biological indicators for moistheat sterilization processes)
	ANSI/AAMI ST79:2017 (Comprehensive guide to steamsterilization and sterility assurance is health care facilities)
CPIS Functionality and Efficacy Report	N/A - No consensus standards exist for this test. Relevantliterature and the standard of care are applicable.
Tooth Surface Damage Study	N/A - No consensus standards exist for this test. Relevantliterature and the standard of care are applicable.

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The following tests were performed to determine the compatibility, functionality and performance of the CPIS. Five tests were performed on the subject device. As no written ISO or other consensus standards are applicable for the aforementioned tests, the peer-reviewed published literature and standard of care is cited as applicable in the study reports.

1. Test Objective: Determination if the CPIS is compatible with the predicate device DSPS torque wrench accessory.
  Outcome: The DSPS torque wrench fit, engaged, retained and easily disengaged from 100% of the CPIS samples.

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Conclusion: This test demonstrates the compatibility of the DSPS torque wrench with the CPIS, and the Substantial Equivalence of the CPIS with the Predicate Device DSPS inserts due to the consistent fit of the DSPS torque wrench on the CPIS shaft square connector which is critical for proper function of the CPIS when connected to the DSPS.

Test Obiective: Determination if the CPIS shaft proximal female threaded connector is compatible with the predicate DSPS handpiece distal end male threaded connector. Outcome: No loosening of the CPIS inserts from the DSPS handpiece was observed in 100% of samples.

Conclusion: This test demonstrates the compatibility of the CPIS with the DSPS handpiece and the Substantial Equivalence of the CPIS with the Predicate Device DSPS, Specifically, the CPIS fits the Predicate Device DSPS handpiece distal male threaded connector and remains securely attached during use.

1. Test Objective: Determination if the CPIS is "as safe and effective" as the predicate (confirming SE) in performing this 510(k) submission's indications for use: soft tissue debridement and periodontal surgery
  Outcome: For all samples in all groups, soft tissue was effectively debrided to expose all intended root surfaces.

Conclusion: This test demonstrates that the CPIS is "as safe and effective" as the predicate (confirming SE) in carrying out this 510(k) stated indications for use of "soft tissue debridement" and "periodontal surgery"; therefore, the CPIS has been shown to be Substantially Equivalent to the Predicate and Reference Devices.

1. Test Objective: Determine if the CPIS is "as safe and effective" as the predicate (confirming SE) in performing this 510(k) submission's for use of: osteotomy. osteoplasty and periodontal surgery.
  Outcome: For all samples in all groups, more than 1mm of bone, but less than 3mm of bone, was removed from around all Mock Resorptive Lesions as intended.

Conclusion: This test demonstrates that the CPIS is "as safe and effective" as the predicate (confirming SE) in carrying out this 510(k) stated indications for use of "osteotomy, osteoplasty, and periodontal surgery": therefore, the CPIS has been shown to be Substantially Equivalent to the Predicate and Reference Devices.

1. Test Objective: Determine if the CPIS PEEK tips and the DSPS inserts damage tooth surfaces._
  Outcome: In all cases, the CPIS QT PEEK tip did not cause any discernible tooth surface damage, while both DSPS inserts caused extensive tooth surface damage. Conclusion: This test demonstrates that the CPIS is safe for use when in contact with tooth structure while the DSPS inserts tested are not safe for use in contact with tooth structure; therefore, the CPIS is superior to the Predicate Device DSPS inserts tested.

Conclusion

The documentation demonstrates that the Contour P-Insert System (CPIS) is substantially equivalent to the predicate and reference devices. It is further concluded that the CPIS is "as safe and effective" as the predicate (confirming SE) as an accessory to the DSPS to carry out the stated indications for use of: osteotomy, osteoplasty soft tissue debridement and periodontal surqery. These conclusions are based on the similarities in intended use, principles of operation, compatibility & functionality, and sterilization method.

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Any differences in materials, design, or geometry have nominal to no impact on safety and do not raise new or different questions of efficacy as clearly demonstrated by the non-clinical studies included with this 510(k) submission.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.