← Product Code [SHI](/productcode/SHI) · K261888 # ClearClub Impression Material (K261888) _ClearClub · SHI · Sep 16, 2026 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K261888 ## Device Facts - **Applicant:** ClearClub - **Product Code:** [SHI](/productcode/SHI.md) - **Decision Date:** Sep 16, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3660 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use The ClearCub Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums to fabricate patient matched nightguards/mouthguards. ## Device Story ClearClub Impression Material is an addition-cure vinyl polysiloxane rubber putty used in dentistry. The material is placed on a preformed impression tray by the user to capture the physical structure of teeth and gums. It functions as a mold-making medium to create an accurate negative replica of the oral anatomy. The resulting impression is used to fabricate custom-fit nightguards or mouthguards. The device is intended for over-the-counter (OTC) use by patients. It is supplied as a non-sterile, two-part putty system (base and catalyst) that is mixed in a 1:1 ratio before application. The material hardens to capture dental detail, which is then used by a laboratory or manufacturer to produce the final dental appliance. ## Clinical Evidence No clinical data. Substantial equivalence is supported by non-clinical bench testing in accordance with ISO 4823 (Dentistry—Elastomeric Impression Materials). Testing confirmed performance metrics including mixing time, consistency (32 mm), linear dimensional change (0.69%), elastic recovery (97.73%), strain in compression (4.52%), and detail reproduction met all acceptance criteria. ## Technological Characteristics Addition-cure vinyl polysiloxane dental impression material. Composition includes vinyl polysiloxane, methylhydrogensiloxane, dimethylsiloxane, dimeticone, white oil, and silicon. Supplied as a non-sterile, two-part putty (base and catalyst) for 1:1 mixing. Complies with ISO 4823 (Type 0) and ISO 1993. Mechanical properties: 32 mm consistency, 0.69% linear dimensional change, 97.73% elastic recovery, 4.52% strain in compression. ## Regulatory Identification Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures. ## Special Controls *Classification.* Class II (Special Controls). ## Predicate Devices - Remi Impression Material ([K251724](/device/K251724.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 16, 2026 ClearClub Pablo Osorio CEO 8915 S La Cienega Blvd. Suite A Inglewood, California 90301 Re: K261888 Trade/Device Name: ClearClub Impression Material Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: SHI Dated: August 20, 2026 Received: August 20, 2026 Dear Pablo Osorio: 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} K261888 - Pablo Osorio 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 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- {2} K261888 - Pablo Osorio Page 3 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. | K261888 | ? | | Please provide the device trade name(s). | | ? | | ClearClub Impression Material | | | | Please provide your Indications for Use below. | | ? | | The ClearCub Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums to fabricate patient matched nightguards/mouthguards. | | | | Please select the types of uses (select one or both, as applicable). | ☐ Prescription Use (Part 21 CFR 801 Subpart D) ☑ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | ClearClub Impression Material Page 7 of 27 {4} K261888 # 510(k) Summary A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92. Submitter: ClearClub Company Contact Person: Pablo Osorio Martini Address: 8915 S La Cienega Blvd STE A, Inglewood, CA 90301 Phone: 424-702-5769 Email: support@joinclearclub.com Date Prepared: 5/18/26 Proprietary Name: ClearClub Impression Material Common Name: Impression Material Product Code: SHI Classification Name : Impression material for fabrication of patient-matched mouthguards, over the counter Device Classification: Class II Predicate Device: Impression Material (K251724) ## Device Description: The ClearClub Impression Material is a neutral-smelling addition-cure rubber impression material used in dentistry that is made of vinyl polysiloxane and other fillers. Vinyl polysiloxane, methylhydrogensiloxane, dimethylsiloxane, dimeticone, white oil, and silicon are all found in the putty base, which is the catalyst. Vinyl polysiloxane, platinum catalyst, dimeticone, white oil, and silicon make up the majority of the catalyst. The product is not sterile. ## Indications for Use: The ClearCub Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums to fabricate patient matched nightguards/ mouthguards. {5} # Comparison to Predicate Devices: Table 1. Predicate Comparison | Specification | Predicate Device: Remi Impression Material | Subject Device: ClearClub Impression Material | Comparison Result | | --- | --- | --- | --- | | Product Code | SHI | SHI | Same | | Classification Panel | Dental | Dental | Same | | Device Class | Class II | Class II | Same | | Classification | 21 CFR 872.3660 | 21 CFR 872.3660 | Same | | Indication for Use | The Remi Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums to fabricate patient matched nightguards/ mouthguards. | The ClearClub Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums to fabricate patient matched nightguards/mouthguards. | Same | | Rx | OTC | OTC | Same | | Material | Vinyl polysiloxane | Vinyl polysiloxane | Same | | Mixing Ratio | 1:1 | 1:1 | Same | | Anatomical Sites | Mouth/Dentition | Mouth/Dentition | Same | | Sterile | Non-Sterile | Non-Sterile | Same | {6} | Specification | Predicate Device: Remi Impression Material | Subject Device: ClearClub Impression Material | Comparison Result | | --- | --- | --- | --- | | Device Description | The Remi Impression Material is an addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. It consists of base and catalyst, in which putty base contains Vinyl polysiloxane, Methylhydrogensiloxane dimethylsiloxane, dimeticone, white oil and silicon. The catalyst mainly contains vinyl polysiloxane, platinum catalyst, dimeticone, white oil and silicon. The product is provided non-sterile. | The ClearClub Impression Material is a neutral-smelling addition-cure rubber impression material used in dentistry that is made of vinyl polysiloxane and other fillers. Vinyl polysiloxane, methylhydrogensiloxane, dimethylsiloxane, dimeticone, white oil, and silicon are all found in the putty base, which is the catalyst. Vinyl polysiloxane, platinum catalyst, dimeticone, white oil, and silicon make up the majority of the catalyst. The product is not sterile. | Equivalent | | Patient Removable? | Yes | Yes | Same | | Testing | ISO 4823 ISO 1993 | ISO 4823 ISO 1993 | Same | | Physical Properties | - Classification according to ISO 4823: Type 0 - Dimensional accuracy: Max.1.5% - Consistency: Max. 35mm - Compatibility with the die and cast materials: 75 μm reproduction - Curve of the shrinkage (Strain in compression): Min.0.8 ~ Max.20% | - Classification according to ISO 4823: Type 0 - Dimensional accuracy: Max.1.5% - Consistency: Max. 35mm - Compatibility with the die and cast materials: 75 μm reproduction - Curve of the shrinkage (Strain in compression): Min.0.8 ~ Max.20% | Same | | Consistency | 32 mm | 32 mm | Same | | Linear dimensional change % | 0.69 | 0.69 | Same | | Elastic recovery | 97.73% | 97.73% | Same | | Strain in compression % | 4.52 | 4.52 | Same | {7} ## Technological Characteristics: The ClearClub Impression Material and predicate are both addition-cure vinyl polysiloxane dental impression materials intended to produce impressions of the teeth and gums for fabrication of patient-matched nightguards. B CDRH Portal oth devices utilize identical polymer chemistry, are supplied as non-sterile putty materials, and are used with preformed impression trays. The devices share the same principle of operation and are manufactured from comparable silicone elastomer formulations. Minor differences in proprietary formulation do not alter the intended use, technological characteristics, or performance of the device. ## Non-Clinical Performance Testing: Non-clinical performance testing was conducted to evaluate the impression performance of the ClearClub Impression Material in accordance with ISO 4823, Dentistry—Elastomeric Impression Materials. Testing included evaluation of mixing time, consistency, linear dimensional change, compatibility with gypsum, elastic recovery, strain in compression, color, and detail reproduction. The test results demonstrated that the subject device met the applicable acceptance criteria specified in ISO 4823, supporting its substantial equivalence to the predicate device. ## Clinical Performance Testing The technological characteristics, indications for use, material, and manufacturing and processes are the same or similar to the predicate device and therefore, no clinical studies were deemed necessary to demonstrate the safety and effectiveness of the subject device. ## Conclusion Based on comparison of indications for use, user population, mechanical and technological features, the ClearClub Impression Material is substantially equivalent to the predicate device. --- **Source:** [https://fda.innolitics.com/device/K261888](https://fda.innolitics.com/device/K261888) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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