Reusable SmartPeg

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 8, 2026 Osstell AB % Cherita James Regulatory Consultant ProPharma Group 1129 20th St. NW Suite 600 Washington, District of Columbia 20036 Re: K261987 Trade/Device Name: Reusable SmartPeg Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: June 12, 2026 Received: June 12, 2026 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261987 - Cherita James Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-reporting-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K261987 - Cherita James Page 3 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-devices/device-advice-comprehensive-regulatory-assistance/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 -S Michael E. Adjodha, MChE, RAC, CQIA 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 {3} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261987 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | Reusable SmartPeg | | | | | Please provide your Indications for Use below. | | | ? | | Reusable SmartPeg is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. | | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | | ? | {4} Osstell AB Reusable SmartPeg 510(k) Summary Sponsor: Osstell AB K261987 Stampgatan 14 411 01 Goteborg Sweden Contact: Cherita James Pro Pharma Group 1129 20th St NW, Suite 600 Washington, DC 20036 Ph. 347-954-0624 Cherita.James@ProPharmaGroup.com Date of Submission: June 12, 2026 Proprietary Name: Reusable SmartPeg Common Name: Dental implant stability analyzer accessory Regulatory Class: Class 1 Regulation: 872.4200 Product Codes: EKX – handpiece, direct drive, ac-powered Primary Predicate Devices: K241065- ChecQ, K143445 Tellos ISQ Buddy Reference Devices: K181888- Osstell Beacon, K033689- Osstell Mentor # Device Description: The reusable SmartPeg is an accessory that will be utilized with Osstell Instruments (Osstell ISQ devices) in an identical fashion as the disposable SmartPeg is utilized with currently marketed Osstell Instruments, e.g. Osstell Beacon (K181888). The change is that the reusable variant is delivered non-sterile and is intended to be cleaned and sterilized between uses in different patients. It can be reprocessed up to 20 times as long as the integrity and performance of the product are maintained. The user is required to inspect it after each cleaning cycle. To facilitate reprocessing, the surface of the SmartPeg body has been treated to improve resistance to oxidation and corrosion during cleaning, disinfection and sterilization. A magnet of identical type, material and size as the magnet in the predicate device but with a protective coating has been chosen for the same reason. There is no change in the principles of operation of the reusable SmartPeg. # Intended Use: The reusable SmartPeg is intended for use as an accessory device for Osstell AB's Dental Implant Stability Analyzers. Page 1 of 6 {5} Ossstell AB Reusable SmartPeg 510(k) Summary # **Indications for Use:** Reusable SmartPeg is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. # **Summary of the Technological Characteristics:** The reusable SmartPeg has the same intended use as the predicate devices currently marketed, and there are no significant differences between the subject and predicate devices that would adversely affect the use. Minor changes in material coatings do not impact the device performance. The stability of the implant is reflected by the resonance frequency of the reusable SmartPeg attached to the implant. The SmartPeg is a small aluminum rod, with a magnet permanently attached to its top. The SmartPeg is screwed onto the implant. The SmartPeg magnet is excited by a small magnetic pulse generated by a coil in the measurement tip. # **Summary of the Nonclinical Testing:** Based on the Risk Analysis, the verification and validation tests, including ISQ performance, sterilization validation, reprocessing performance validation and device usability were performed and the acceptance criteria applied. The subject device and primary predicate reusable products are delivered non-sterile and are reprocessed for multi patient use. The Osstell Beacon was subjected to the same applicable preclinical requirements and testing for the “peg” as the predicate devices. Performance testing was conducted to confirm compliance to the design specifications. Testing and documentation has been performed to the following standards: | Standard | Title | | --- | --- | | ISO 13485:2016 | Medical devices - Quality management system - Requirements for regulatory purposes | | ISO 14971:2019 | Medical devices – Application of risk management to medical devices | | ISO 15223-1:2021 | Medical devices – Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements | | ISO 20417:2021 | Medical devices - Information to be supplied by the manufacturer | | ISO 17664-1:2021 | Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices Part 1: Critical and semi-critical medical devices | | ISO 10993-1:2018 | Biological evaluation of medical devices – Part 1: Evaluation and testing | | ISO 17665:2024 | Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices | Page 2 of 6 {6} Osstell AB Reusable SmartPeg 510(k) Summary ### Substantial Equivalence Discussion: The principles of operation are the same as predicate and reference devices. The use of a reusable SmartPeg, with a very brief attachment to a dental implant before being removed and reprocessed, is similar to the use and reprocessing of accessory “pegs” of the predicate and reference devices, as well as other accessories commonly used with dental implants (which are 510(k) exempt under product code NDP), such as screwdrivers, impression copings and scan bodies. ### Clinical Data: Clinical studies were not required to validate the modifications to the SmartPeg. ### Conclusion: The modified reusable SmartPeg has the following similarities to the predicate and reference “pegs”: - 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 (medical grade) in the accessory. There is no difference in the intended use or technological characteristics; minor differences in material and reprocessing should not render the SmartPeg reusable NSE as it does not affect the safety and effectiveness nor raise different questions in that regard. Page 3 of 6 {7} Osstell AB Reusable SmartPeg 510(k) Summary | | Subject Accessory: SmartPeg (reusable) | Predicate Device: ChecQ | Predicate Device: Tellos ISQ Buddy | Reference Device: Osstell Beacon | Reference device: Osstell Mentor | Substantial Equivalence discussion | | --- | --- | --- | --- | --- | --- | --- | | K# | To be assigned | K241065 | K143445 | K181888 | K033689 | - | | Device name | SmartPeg (reusable) | ChecQ with reusable ChecQPEG | Tellos ISQ Buddy (marketed as Penquin RFA) with reusable ISQ Pegs | Osstell Beacon with disposable SmartPeg | Osstell Mentor with disposable SmartPeg | - | | Company name | Osstell AB | Dentis | Tellos Medical AB | Osstell AB | Integration Diagnostics Ltd. | - | | Classification | Class I | Same | Same | Same | Same | - | | Regulation number | 872.4200 | Same | Same | Same | Same | - | | Classification name/product code | Handpiece, direct drive, ac-powered/EK X | Same | Same | Same | Same | - | | Intended use | Accessory to Osstell Instruments (dental implant stability analyzers). The stability of the implant is reflected by the resonance frequency of the “SmartPeg (reusable)” attached to the implant. | Dental implant stability analyzer. The stability of the implant is reflected by the resonance frequency of the ChecQPEG accessory attached to the implant. | Dental implant stability analyzer. The stability of the implant is reflected by the resonance frequency of the ISQ Peg accessory attached to the implant. | Dental implant stability analyzer. The stability of the implant is reflected by the resonance frequency of the “SmartPeg” attached to the implant. | Dental implant stability analyzer. The stability of the implant is reflected by the resonance frequency of the “SmartPeg” attached to the implant. | SmartPegs were cleared as accessories with previous Osstell instruments (K181888, K033689) A similar accessory called ISQ Peg was cleared with the predicate device K143445, and another called ChecQPEG was cleared with K241065 | | Indication for use | Indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. | Same | Same | Same | The Osstell Mentor is indicated for use in measuring the stability of implants in the oral cavity and | Same indication for use. (FDA requested change from craniofacial to maxillofacial in more recent | Page 4 of 6 {8} Osstell AB Reusable SmartPeg 510(k) Summary | | Subject Accessory: SmartPeg (reusable) | Predicate Device: ChecQ | Predicate Device: Tellos ISQ Buddy | Reference Device: Osstell Beacon | Reference device: Osstell Mentor | Substantial Equivalence discussion | | --- | --- | --- | --- | --- | --- | --- | | | | | | | craniofacial region. | EKX cleared devices.) | | Location of Use/user | Dental practice or operating room. Professional clinicians | Same | Same | Same | Same | Same use environment Same intended user | | Description of Accessory | The SmartPeg is a small aluminum rod, approximately 3 mm in diameter and 10 mm long, with a magnet permanently attached to its top. The SmartPeg is screwed onto the implant. The SmartPeg magnet is excited by a small magnetic pulse generated by a coil in the measurement tip. The SmartPeg vibrates freely at the resonance frequency for some milliseconds. By means of the magnet, the vibration (the "ringing") can be picked up by a second coil in | ...the Titanium ChecQPEG, which attaches to the dental implant, and measures stability by analyzing resonant frequencies generated by magnetic field stimulation from the probe tip. ... The ChecQ mechanism converts voltage pulses generated by the DAC of the MCU into magnetic pulses, which induce vibrations in the ChecQPEG magnets. The device captures the free vibrations as magnetic pulses, | Tellos ISQ Buddy uses the Osstell SmartPegs, or corresponding Tellos pins, "ISQ Pegs" from titanium. ISQ Pegs are reusable for multi-patient use | The stability of the implant is reflected by the resonance frequency of the "SmartPeg" attached to the implant. The SmartPeg is a small aluminum rod, approximately 3 mm in diameter and 10 mm long, with a magnet permanently attached to its top. The SmartPeg is screwed onto the implant. The SmartPeg magnet is excited by a small magnetic pulse generated by a coil in the measurement tip. The SmartPeg vibrates freely at the resonance frequency for | The stability of the implant is reflected by the resonance frequency of a "SmartPeg" attached to the implant. The SmartPeg is a small aluminum rod, approximately 3 mm in diameter and 10 mm long, with a magnet permanently attached to its top. The SmartPeg is screwed onto the implant. The SmartPeg magnet is excited by a small magnetic pulse generated by a coil in the measurement probe. The SmartPeg vibrates freely at its resonance frequency for some | Same material as the SmartPeg cleared with the reference device K181888 except that the new SmartPeg is reusable. The pegs used for predicates K143445 and K241065 are also reusable. The difference in peg materials do not raise different questions of the safety or effectiveness of the pegs for their intended use and both have provided biocompatibility testing applicable for their intended use. | Page 5 of 6 {9} Osstell AB Reusable SmartPeg 510(k) Summary | | Subject Accessory: SmartPeg (reusable) | Predicate Device: ChecQ | Predicate Device: Tellos ISQ Buddy | Reference Device: Osstell Beacon | Reference device: Osstell Mentor | Substantial Equivalence discussion | | --- | --- | --- | --- | --- | --- | --- | | | the instrument tip. The SmartPeg is reusable for multi-patient use | processes them ... ChecQPEG are reusable for multi-patient use | | some milliseconds. By means of the magnet, the vibration (the “ringing”) can be picked up by a second coil in the instrument tip. The SmartPeg provided with K181888 is single use, disposable | milliseconds. Since the magnet attached to its top is vibrating together with the SmartPeg, the vibration (the “ringing”) can be picked up by a second coil in the measurement probe. | | | Sterile components/methods | SmartPeg is reusable for multi-patient use. Delivered non-sterile. Cleaning, disinfection and sterilization by user required. | ChecQ Peg delivered non-sterile. Cleaning and sterilization by user required. | ISQ Peg delivered non-sterile. Cleaning and sterilization by user required. | SmartPeg for single patient use. Delivered sterile ready to use. | The SmartPeg is provided sterile and is disposable after each patient use. | The pegs used for predicate devices K143445 and K241065 are also reusable. | Page 6 of 6