The Osstell Beacon is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell Beacon is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement tip on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the implant and is derived from the resonance frequency value obtained from the Smartpeg.

AI/ML Overview

The provided document, a 510(k) summary for the Osstell Beacon device, does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against such criteria. The document focuses on demonstrating substantial equivalence to a predicate device (Osstell ISQ K082523) by detailing technological characteristics rather than presenting a performance study with acceptance criteria.

However, based on the nonclinical testing section, it can be inferred that performance testing was conducted to confirm compliance to design specifications. Since the document claims the "Beacon performs as intended" and lists "Accuracy: ±2 ISQ units" under its specifications, we can reasonably extrapolate this accuracy as an implicit acceptance criterion.

Here's a breakdown of the requested information, with disclaimers about missing details:

1. Table of Acceptance Criteria and Reported Device Performance

Given the information, an explicit table of acceptance criteria and a detailed performance study are not provided in this 510(k) summary. However, an inferred acceptance criterion for accuracy exists:

Acceptance Criteria (Inferred)	Reported Device Performance
Accuracy: ±2 ISQ units	Accuracy: ±2 ISQ units

Note: This is an inferred acceptance criterion based on the device's stated accuracy in its specifications and the claim that performance testing confirmed compliance to design specifications. The document does not explicitly state this as an acceptance criterion from a study protocol.

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

The document states: "Performance testing was conducted to confirm compliance to the design specifications." However, it does not provide any specific sample size for a test set or details about the data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document does not mention the use of experts to establish ground truth for any test set. The device likely provides direct measurements rather than relying on expert interpretation for its core function.

4. Adjudication Method for the Test Set

Since no involvement of experts in establishing ground truth or a test set is explicitly described, there is no mention of an adjudication method.

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

The document states: "Clinical studies were not required to validate the modifications in the Osstell Beacon." This implies that no MRMC comparative effectiveness study was conducted. The device is a measurement tool, and the submission focuses on its equivalence to a predicate device rather than human reader performance with or without AI assistance.

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

The document indicates that "Performance testing was conducted to confirm compliance to the design specifications." The device operates as an "Implant Stability Analyzer" that provides an "Implant Stability Quotient (ISQ)" value directly. This implies a standalone performance evaluation of the algorithm's ability to accurately measure the resonance frequency and calculate the ISQ value. The "Accuracy: ±2 ISQ units" is a standalone performance metric.

7. Type of Ground Truth Used

The type of ground truth used for the performance testing is not explicitly stated but can be inferred as a reference measurement of resonance frequency or implant stability against which the device's calculated ISQ value would be compared. For a measurement device, this typically involves using a highly accurate, calibrated system or a known physical property (e.g., a standard with a known resonance frequency).

8. Sample Size for the Training Set

The document focuses on substantial equivalence and nonclinical testing. It does not mention any training set size because the device's underlying technology (Resonance Frequency Analysis and ISQ software algorithm) is based on established physical principles and is inherited from its predicate device (Osstell ISQ K082523), rather than requiring a machine learning model that needs a training set.

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

As there is no mention of a training set being used in the context of machine learning, there is no information on how its ground truth might have been established. The device relies on a physical measurement and algorithm, not a trainable model.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 22, 2019

Osstell AB % Cherita James Regulatory Consultant M Squared Associates, Inc 575 8th Ave Suite 1212 New York, NY 10018

Re: K181888

Trade/Device Name: Osstell Beacon Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX Dated: July 23, 2019 Received: July 24, 2019

Dear Cherita James:

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.

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medical-devicereporting-mdr-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 Nandkumar, Ph.D. Acting Assistant 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

510(k) Number (if known) K181888

Device Name Osstell Beacon

Indications for Use (Describe)

Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

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)

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510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for the Osstell Beacon 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

Sponsor:	Osstell ABStampgatan 14411 01 GoteborgSweden
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Contact: Cherita James M Squared Associates, Inc. 575 8th Ave, Suite 1212 New York, New York 10018 Ph. 347-954-0624 Fax. 703-562-9797 CJames@MSquaredAssociates.com

Revision Date:	August 19, 2019
Proprietary Name:	Osstell Beacon
Common Name:	Dental implant stability analyzer
Regulatory Class:	Class 1
Regulation:	872.4200
Product Codes:	EKX - handpiece, direct drive, ac-powered
Predicate Device:	Osstell ISQ (K082523)-Primary
Tellos ISO Buddy (K143445) and Implantmed SI-1015 (K161957)- Reference

Device Description:

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K181888

derived from the resonance frequency value obtained from the Smartpeg.

Intended Use:

Osstell Beacon is intended for use as a Dental Implant Stability Analyzer

Indications for Use:

Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.

Summary of the Technological Characteristics:

The modifications to the Osstell ISQ since its previous clearance in K082523 include the following changes:

. Enclosure design is smaller to be fully handheld. The measurement probe with tip is integrated into the enclosure and referred to as the measurement tip
. Not possible to sterilize (autoclave). The device must be used with a transparent barrier sleeve. Commercially available transparent, barrier sleeves are recommended in the Instructions for Use.
Different plastic material used in the enclosure (all being food grade compliant, 21 CFR §181.32 and 21 CFR §177.1580)
. Updated user interface to make the measurement procedure even more easy and intuitive
The device cannot measure while charging
Bluetooth data communication .

These differences do not affect the substantial equivalence or performance of the device and do not change the intended use of the Osstell Beacon.

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K181888

Summary of the Nonclinical Testing:

Based on the Risk Analysis, the verification and validation testing confirms the Beacon performs as intended. The Osstell Beacon was subjected to the same preclinical requirements and testing as the primary predicate device.

Though the recommendation require use of a transparent barrier sleeve, due to material changes, the device was evaluated in accordance with ISO 10993-1.

Additionally, cleaning and disinfection recommendations were validated in the event the Osstell Beacon should become contaminated due to a damaged barrier sleeve.

Performance testing was conducted to confirm compliance to the design specifications.

Osstell has provided information to support compliance of Beacon with applicable portions of the following standards and FDA Guidance documents:

FDA Dental Handpieces Premarket Notification [510(k)] Submissions, 2007 ●
. FDA Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015
. FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005
. ISO 10993-1
. ISO 10993-5
. AAMI TIR12:2010
AAMI TIR30:2011
. ASTM E1837-96 (2014)
ISO 17665-1
ISO 17664
IEC 60601-1, Ed 3 2005 ●
. IEC 60601-1-2:2015
. IEC 62133

Substantial Equivalence Discussion:

The changes to the enclosure, no longer capable to withstand sterilization and instead use of barrier sleeves, electronics, user interface and communication do not change the intended use, nor do they affect the substantial equivalence as compared to the Osstell ISQ previously cleared in

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K082523.

	OsstellBeacon	PredicateDevice: OsstellISQ	ReferenceDevice:Tellos ISQBuddy	Reference Device:Implantmed SI-1015 incl.Accessories	SubstantialEquivalence
K#	To be assigned	K082523	K143445	K161957
Device name	Osstell Beacon	Osstell® ISQ	Tellos ISQBuddy(marketed asPenquin RFD)	Implantmed SI-1015incl. Accessories	-
Company name	Osstell AB	Osstell AB	Tellos MedicalAB	W & HDENTALWERKBÜRMOOS GMBH
Classification	Class I	Same	Same	Same	-
RegulationNumber	872.4200	Same	Same	Same	-
Classificationname	Handpiece,Direct Drive,AC-powered	Same	Same	Same	-
Intended Use	Dental implantstabilityanalyzer	Same	Same	Mechanical drive fordental instrumentswith ISQ moduleused to measureimplant stability.	Same
Indication foruse	Indicated for usein measuring thestability ofimplants in theoral cavity andmaxillofacialregion.	Indicated for usein measuring thestability ofimplants in theoral cavity andcraniofacialregion.	Indicated for usein measuring thestability ofdental implantsin the oralcavity and themaxillofacialregion.	Mechanical drive unitwith coolant supplyfor transmissioninstrumentswith ISO 3964(DIN13940)compatible couplingsystem, for use indental surgery,implantology andmaxillofacial surgery(CMF) for treatmentof dental hard tissue.Includes ISQ moduleused to measureimplant stability.	Subject, primarypredicate, andK143445reference deviceare identical.K161957reference deviceused forBluetoothtechnology has adifferentindication,however thecomparison isonly forBluetoothtechnology anddoes not havespecificindications forthis technology
Description	Portable,handheldbattery driveninstrumentindicated for usein measuring thestability ofimplants in theoral cavity andmaxillofacialregion.	Portable,handheld, orfreestandinginstrumentindicated for usein measuring thestability ofimplants in theoral cavity andcraniofacialregion.	Hand-held.battery-drivendevice formeasuring therelative stabilityof a dentalimplant.	- the control unit.- a motor with cablewith or without light(EM-19 LC/EM-19),- a wireless or wiredfoot control (S-NWor S-N2).- the Osstell Module(SI-SQ)- and as an attachmentthe surgicalhandpieces	All are portablehandhelddevices, thechange inconfigurationcompared to ISQwhichincorporates thedevice controlsand displays intoa single handhelddoes not impactthe substantial
	OsstellBeacon	PredicateDevice: OsstellISQ	ReferenceDevice:Tellos ISQBuddy	Reference Device:Implantmed SI-1015 incl.Accessories	SubstantialEquivalence
				- (WS-56 L, WS-75L, WS-91 L, WS-92L and S-11 L).The user can selectfive differentprograms. Switchingbetweenthese programs isperformed by footcontrol or via touchdisplay.	the device.ISQ Buddy isalso portable,handheld andImplantmed usesa wireless footpedal viaBluetoothtechnology.Verification ofthe Beaconconfirms itperforms asintended.
Operation ofSystem	Measures thefrequencyresponse fromSmartpeg that isdirectly attachedto the implant orabutment. Thesystem includesthe followingcomponents:Instrument,OsstellSmartpeg,OsstellSmartPegMount, OsstellUSB cable,Osstell TestPegThe techniqueinvolves aSmartPeg (10mm x 3 mm)that is attachedto the implant orabutment. TheSmartPeg isexcited over arange offrequencies (1kHz to 10 kHz)and theresonancefrequency ismeasured withthe OsstellBeaconinstrument andsoftware. Theresonancefrequency is	Measures thefrequencyresponse fromSmartpeg that isdirectly attachedto the implant orabutment. Thesystem includesthe followingcomponents:Instrument,Osstell SmartPeg,OsstellMeasurementProbe, OsstellSmartPeg Mount,Osstell USBCable, OsstellTestPegSame technique isused in operatingthe system as theOsstell Beacondevice.	Amicrocontrollersends electricpulses to a coilin theinstrument tip.As aconsequence,magnetic pulsesare emitted thataffect the pinconnected to theimplant. The pinthen starts tovibrate with itsresonancefrequency.Vibrationcreates analternatingmagnetic fieldwhich is beingpicked up byanother coil inthe instrumenttip. Theelectrical signalfrom thereceiving coil isanalyzed andthe frequency isdetermined. TheFrequency ispresented on thedisplay as an"ISQ- value"Resonancefrequency of theISQ peg as anISQ number, 1-	Referenced specificto wireless foot pedal;however, devicesinclude a ISQ moduleused to measureimplant stability.	There is nodifference in thesystem operationbetween thesubject deviceand K082523 orK143445.
	OsstellBeacon	Predicate Device: OsstellISQ	ReferenceDevice:Tellos ISQBuddy	Reference Device:Implantmed SI-1015 incl.Accessories	SubstantialEquivalence
	the stiffness ofthe implantsystem. TheOsstell Beaconpresents theresonancefrequency as anImplantStabilityQuotient (ISQ)value (scaled 0-100). The ISQvalue isproportional tothe stability ofthe implant.(In general, anincrease in ISQvalue from onemeasurementtime to the nextindicates aprogressiontowards higherstability and alower ISQ valuemay indicate aloss in stabilityand perhaps,implant failure.)Bluetoothfunctionality fordeviceproduction	number iscalculated fromthe resonancefrequency.
	purposes only
SystemComponents	InstrumentA portable,handheldinstrument with2 built-ingraphicaldisplays. Theunit operatesfrom arechargeablepower sourceoffering morethan 400 ISQmeasurementsbetweencharges.The size of thedisplays is 14 x11 mm.	InstrumentA portable,handheld, orfreestandinginstrument withbuilt-in graphicaldisplay. The unitoperates from arechargeablepower sourceoffering over 6hours ofcontinuous usebetween charges.The size of theLCD display is 69x 37 mmThe instrumentcan be connectedto a PC via theUSB cable and the	Tellos ISQBuddyinstrument, ISQPeg, ISQ PegDriver andinstrumentcharger.Tellos ISQBuddy has twoLED-displays;one on each sideof theinstrument foreasy reading.Tellos ISQBuddy uses theOsstellSmartPegs, orcorrespondingTellos pins,	- the control unit,- a motor with cablewith or without light(EM-19 LC/EM-19),- a wireless or wiredfoot control (S-NWor S-N2),- the Osstell Module(SI-SQ)- and as anattachment thesurgical handpieces- (WS-56 L, WS-75L, WS-91 L, WS-92L and S-11 L).	The change inconfiguration andcomponents fromthe ISQ whichincorporates thedevice controlsand displays intoa single handheldfor the Beacondoes not impactthe substantialequivalence ofthe device.Tellos ISQBuddy also isportable,handheld devicewith LEDdisplays, andemploys"SmartPegs or
OsstellBeacon	PredicateDevice: OsstellISQ	ReferenceDevice:Tellos ISQBuddy	Reference Device:Implantmed SI-1015 incl.Accessories	SubstantialEquivalence
Themeasurement tip	can be transferredto the optional	"ISQ Pegs"from titanium.		ISQ Pegs. TheImplantmed SI
is held close tothe Smartpeg.The	ISQ Data ManagerSoftware.			device, isreferencedspecific to
measurementelectronicssends theexcitation signal	MeasurementProbe with tipThe MeasurementProbe is connected			wireless footpedal, which alsoutilizes Bluetoothsoftware
to the coils inthe tip, and also	to the instrumentvia the probe			functionality..
detects theresponse signalfrom thedetection coil in	cable and is heldclose to theSmartpeg. Themeasurement			Verification ofthe Beaconconfirms it
the tip. Themicrocontrollerin the	electronics sendsthe excitationsignal to the coil			performs asintended.
instrumentcalculates thefrequency of the	in the probe withtip, and alsodetects the
response signal,and presents iton the display	response signalfrom the detectioncoil in the probe
as a number, theImplantStability	with tip. Themicrocontroller inthe instrument
Quotient (ISQ).Smartpeg	calculates thefrequency of theresponse signal,
The stability ofthe implant isreflected by the	and presents it onthe display as anumber, the
resonancefrequency of the"Smartpeg"	Implant StabilityIndex (ISQ).The measurement
attached to theimplant. TheSmartpeg is a	probe has fixedcable.
small aluminumrod,approximately 3	SmartpegSame- No changeto the Smartpeg
mm in diameterand 10 mmlong, with a	Datacommunication
magnetpermanentlyattached to its	The Osstell ISQData Manager is aWindows
top. TheSmartpeg isscrewed onto	2000/NT/XP/Vistabased softwareenabling storage,
the implant.The Smartpegmagnet is	viewing andprinting ofmeasured data.
excited by asmall magneticpulse generated	The Software is anoptional accessoryto the Osstell ISQ
by a coil in the	and is not integral
	OsstellBeacon	PredicateDevice: OsstellISQ	ReferenceDevice:Tellos ISQBuddy	Reference Device:Implantmed SI-1015 incl.Accessories	SubstantialEquivalence
Power, Weightand Size	measurementtip. TheSmartpegvibrates freelyat the resonancefrequency forsomemilliseconds.By means of themagnet, thevibration (the"ringing") canbe picked up bya second coil inthe instrumenttip.BluetoothcommunicationThe OsstellBeacon containsa built inBluetooth 4.0low energymodule devicefor productionpurposes only.Power source:Lithium-ion cell	to the clinicalfunctioning of thedevice.Power source:Lithium-ion cell	Re-chargeableNiMh-batteries	Main dimension:154x202x210	Minordifferences inpower, weightand size do notaffect theperformance ofthe Beacon whencompared to theOsstell ISQ.ISQ Buddy isalso portable,handheld. TheImplantmeddevice is onlyreferenced for itsuse of aBluetoothwireless footpedal.
	(3.7V, 0.8 Ah)Instrument Size:210 x 35 x 25mmInstrumentWeight: 0.07kgAccuracy: ±2ISQ units	(3.7V, 2.2 Ah)Instrument Size:190 x 120 x 45mmInstrumentWeight: 0.4 kgAccuracy: ±2 ISQunits		Features:4 buttons for pumpon/offForward/reverseChange programsMotor control (on/offand variable)Power supply:wirelessvia 3xAA batteries
Instrumentmaterials	ABS and PCPlastic	ABS and PCplastic	PC/ABS	N/A: Onlyreferenced specific towireless foot pedal.	No change.
Probe TIPmaterials	ABS Plastic	Probe: PPSU,stainless steelCable: siliconeCable connector:Naturalpolyestersulfone	PEEK	N/A: Onlyreferenced specific towireless foot pedal.	Materials do noteffect the deviceperformance.Beacon performsas intended.
	OsstellBeacon	PredicateDevice: OsstellISQ	ReferenceDevice:Tellos ISQBuddy	Reference Device:Implantmed SI-1015 incl.Accessories	SubstantialEquivalence
Device Display	2 pcs OLED -displays 14 x 11mm	LCD - 69x 37-mm	LED	N/A: Onlyreferenced specific towireless foot pedal.	Beacon displaymeets therequirements ofthe end user andis same as ISQBuddy.
Software Testingand Validation	System andsoftwareverification andvalidationperformed.	Same	Unknown	For the new wirelessfoot control (S-NW)softwareverification/validationof the functions of thefoot control wasconducted accordingto IEC 62304:2006.	No change insoftware requiredfor theconfigurationchanges.
Mechanical/Electrical safety/Standards	The OsstellBeacon isdesigned andmanufacturedwith applicablestandards:IEC 60601-1IEC 60601-1-2IEC 62133	Same	Same	EMC testing wasperformed to evaluatethe risk ofcommunicationloss according to IEC60601-1-2:2007 andElectrical SafetyTests done accordingto IEC 60601-1-1:2005.	All devicessubstantiallyequivalent forintended use
Sterilecomponents/methods	Instrument notsterile andcannot beautoclaved/Mustuse atransparent,barrier sleeveSmartPeg/single patientuse	Probe with cable/autoclaveSmartPeg /singlepatient use	Instrument notsterile andcannot beautoclaved/Mustuse atransparent,barrier sleeveISQ Peg/re-sterilized	Surgical Handpieces	Transparentbarrier use in theBeacon ensure nocrosscontaminationbetween patients.
InstrumentCleaning andDisinfection	Intended for usewith transparentbarrier ensureno crosscontaminationbetweenpatients.Validatedcleaning andHLD in theevent of barrierdamage.	Patient contactingprobe sterilizable	Intended for usewith transparentbarrier ensureno crosscontaminationbetweenpatients.	Cleaning: rinse underdemineralizedwater (< 38°C/100°F)with aid of brushDisinfection: wipingdisinfection usingdisinfectant clothsSterilization:Dynamic-air-removalSterilizers or Gravitydisplacementsterilizers	Both TellosBuddy ISQ andBeacon employsleeves to protectagainstcontamination.Tellos Usermanual does notdefine validatedcleaning anddisinfectionsteps.
Contraindication	Osstell Beaconiscontraindicatedfor implantsystems towhich theSmartPeg could	Same	Unknown	Unknown	No change incontraindications.
	OsstellBeacon	PredicateDevice: OsstellISQ	ReferenceDevice:Tellos ISQBuddy	Reference Device:Implantmed SI-1015 incl.Accessories	SubstantialEquivalence
	not be attachedfor mechanicalincompatibilityreasons.Osstell Beaconiscontraindicatedwhere it is notpossible toattach theSmartPeg due tolack of space, orwhere itimpinges onother artificialor anatomicalstructures.
Location of Use	Dental practiceor operatingroom.	Dental practice oroperating room.	Dental practiceor operatingroom.	Dental practice orclinic	Same useenvironment.
User	Professionalclinicians	Professionalclinicians	Professionalclinicians	Professionalclinicians	Same intendeduser

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Clinical Data:

Clinical studies were not required to validate the modifications in the Osstell Beacon.

Conclusion:

The modified Osstell Beacon has the following similarities to the Osstell ISQ previously cleared in K082523:

has the same intended and indicated use, to be used for the same professional clinicians . and in the same environment
it uses the same operating principle of utilizing Osstell RFA measurement technology, . circuitry and ISQ software algorithm
Biologically equivalent materials (food grade) in the instrument tip. .
it uses the same, single use, measurement pins, i.e. the Osstell SmartPegs

The modifications to the Osstell Beacon can therefore be found substantially equivalent to the Osstell ISQ cleared in K082523, as well as features of the Tellos ISQ Buddy (K143445) and

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K181888

Implantmed SI-1015 (K161957.

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.