← Product Code [EMA](/productcode/EMA) · K261937 # PacTemp Automix NE (K261937) _The Belport Company Inc., DBA Gingi-Pak · EMA · Aug 7, 2026 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K261937 ## Device Facts - **Applicant:** The Belport Company Inc., DBA Gingi-Pak - **Product Code:** [EMA](/productcode/EMA.md) - **Decision Date:** Aug 7, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3275 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use PacTemp Automix NE is indicated for temporization of provisional prostheses or restorative procedures, including provisional crowns, bridges, inlays, and onlays. ## Device Story PacTemp Automix NE is a non-eugenol, resin-based temporary dental cement; supplied as a two-component system (base and catalyst pastes) in a dual-barrel syringe with disposable mixing tips. Used by dental professionals in clinical settings for provisional cementation of crowns, bridges, inlays, and onlays. Upon mixing, material undergoes a chemically activated curing reaction to form a temporary luting material. Provides temporary retention and removability for provisional restorations. Benefits include ease of handling, mixing, and seating during restorative procedures. ## Clinical Evidence Bench testing only. No clinical data. Performance evaluated against ISO 9917-2:2017 and recognized dental cement test methods. Metrics compared: shear bond strength (14.8 MPa vs 13.6 MPa), flexural strength (27.4 MPa vs 21.2 MPa), water solubility (0.4 vs 0.8 μg/mm³), water sorption (32 vs 28 μg/mm³), working time (90-120s vs 100-150s), setting time (<4 min vs <5 min), radiopacity (190% vs 180% Aluminum), and film thickness (22.5 μm vs 20 μm). Biocompatibility assessed per ISO 10993-1. ## Technological Characteristics Resin-based, non-eugenol temporary dental cement. Composition: methacrylate monomers, fillers, initiators, stabilizers, pigments. Principle: chemically activated (self-cure) polymerization. Delivery: dual-barrel syringe with disposable mixing tips. Non-sterile. Performance standards: ISO 9917-2:2017. No software or electronic components. ## Regulatory Identification Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. ## Predicate Devices - UltraTemp Rez II ([K211237](/device/K211237.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} **U.S. FOOD & DRUG** ADMINISTRATION August 7, 2026 The Belport Company Inc., DBA Gingi-Pak Nikki Huynh Regulatory Affairs Specialist 4825 Calle Alto Camarillo, California 93012 Re: K261937 Trade/Device Name: PacTemp Automix NE Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: June 9, 2026 Received: June 10, 2026 Dear Nikki Huynh: 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261937 - Nikki Huynh Page 2 (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-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). {2} K261937 - Nikki Huynh Page 3 Sincerely, ![img-0.jpeg](img-0.jpeg) For Michael E. Adjodha, M.ChE., 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. | K261937 | ? | | Please provide the device trade name(s). | | ? | | PacTemp Automix NE | | | | Please provide your Indications for Use below. | | ? | | PacTemp Automix NE is indicated for temporization of provisional prostheses or restorative procedures, including provisional crowns, bridges, inlays, and onlays. | | | | 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) | ? | {4} K261937 ## 510(k) Summary Submitter: The Belport Company, Inc., dba Gingi-Pak Address: 4825 Calle Alto, Camarillo, CA 93012 Contact Person: Nikki Huynh Title: Regulatory Specialist Phone: (805) 484-1051 Email: nikki.huynh@gingi-pak.com Date Prepared: 06/08/2026 Trade Name: PacTemp Automix NE Common Name: Temporary Dental Cement Submission Type: Traditional 510(k) Submission Number: K261937 Regulation Name: Dental Cement Regulation Number: 21 CFR 872.3275 Product Code: EMA Device Class: Class II ## Device Description PacTemp Automix NE is a non-eugenol temporary resin dental cement intended for professional dental use in provisional cementation procedures. The device is supplied as a two-component automix system consisting of base and catalyst pastes delivered through a dual-barrel syringe with disposable mixing tips. Upon mixing, the material undergoes a chemically activated curing reaction to form a temporary resin cement. ## Indications for Use PacTemp Automix NE is indicated for temporization of provisional prostheses or restorative procedures, including provisional crowns, bridges, inlays, and onlays. ## Predicate Device The following legally marketed device was used as the predicate device: 510(k) Number: K211237 Summary_PacTemp Automix NE_Rev.062426 Page 1 of 4 {5} 510(k) Trade Name: UltraTemp Rez II Manufacturer: Ultradent Products, Inc. Address: 505 W 10200 S, South Jordan, UT 84095 Regulation Number & Code: 21 CFR 872.3275; EMA Regulation Name: Dental Cement Regulatory Class: Class II Clearance Date: July 13, 2021 ## Technological Characteristics PacTemp Automix NE is a resin-based, non-eugenol temporary dental cement utilizing methacrylate resin chemistry and a chemically activated curing mechanism. The device is supplied in an automix dual-barrel syringe delivery format and is intended for professional dental use. A comparison of the technological characteristics of the subject device and predicate device is provided below: | Parameter | Subject Device PacTemp Automix NE | Predicate Device UltraTemp Rez II (K211237) | Substantial Equivalence with Predicate Device | | --- | --- | --- | --- | | Manufacturer | The Belport Company, Inc., dba Gingi-Pak | Ultradent Products, Inc. | | | Product Type | Non-eugenol temporary dental cement | Non-eugenol temporary dental cement | Substantially equivalent | | Regulatory Class | Class II | Class II | Substantially equivalent | | Sterility | Non-sterile | Non-sterile | Substantially equivalent | | Intended User | Professional dental use | Professional dental use | Substantially equivalent | | Indications for Use | For temporization of provisional prostheses or restorative procedures (i.e. provisional crowns, bridges, inlays, and onlays) | For temporization of provisional prostheses or restorative procedures (i.e. provisional crowns, bridges, inlays, and onlays) | Same intended use | | Principle of Operation | Two-component temporary cement that sets after mixing to form a temporary luting material | Two-component temporary cement that sets after mixing to form a temporary luting material | Substantially equivalent | Summary_PacTemp Automix NE_Rev.062426 Page 2 of 4 {6} | Parameter | Subject Device PacTemp Automix NE | Predicate Device UltraTemp Rez II (K211237) | Substantial Equivalence with Predicate Device | | --- | --- | --- | --- | | Curing / Setting Mechanism | Chemical cure / self-cure after mixing of base and catalyst | Chemical cure / self-cure after mixing of base and catalyst | Substantially equivalent | | Delivery Format | Automix dual-barrel syringe with disposable mixing tips | Automix dual-barrel syringe with disposable mixing tips | Substantially equivalent | | Design | Two-component base/catalyst system | Two-component base/catalyst system | Substantially equivalent | | Material Type | Resin-based temporary dental cement | Resin-based temporary dental cement | Substantially equivalent | | Eugenol Content | Non-eugenol | Non-eugenol | Substantially equivalent | | Handling Characteristics | Easy handling, mixing, seating, temporary retention, and removability. | Easy handling, mixing, seating, temporary retention, and removability. | Substantially equivalent | | **Composition** | | | | | Chemical Composition | Resin-based temporary dental cement containing methacrylate monomers, fillers, initiators, stabilizers, and pigments. | Resin-based temporary dental cement containing methacrylate monomers, fillers, initiators, stabilizers, and pigments. | Both devices utilize methacrylate resin chemistry and the same fundamental scientific technology. | | **Non-Clinical Performance Test Data** | | | | | Performance Standard | ISO 9917-2 and recognized dental cement test methods | ISO 9917-2 and recognized dental cement test methods | Substantially equivalent | | Shear bond strength (MPa) | 14.8 | 13.6 | Substantially equivalent | | Flexural Strength (MPa) | 27.4 | 21.2 | Substantially equivalent | | Water Solubility (μg/mm³) | 0.4 | 0.8 | Substantially equivalent | | Water Sorption (μg/mm³) | 32 | 28 | Substantially equivalent | | Working Time (seconds) | 90-120 | 100-150 | Substantially equivalent | | Setting Time (minutes) | < 4 | < 5 | Substantially equivalent | | Radiopacity (% Aluminum) | 190 | 180 | Substantially equivalent | | Film Thickness (μm) | 22.5 | 20 | Substantially equivalent | ## Performance Data Summary_PacTemp Automix NE_Rev.062426 Page 3 of 4 {7} Bench testing was conducted to evaluate physical and functional performance characteristics relevant to the intended use of the device. Testing included: - Shear bond strength - Flexural strength - Water solubility - Water sorption - Working time - Setting time - Radiopacity - Film thickness Testing was conducted using ISO 9917-2:2017 and recognized dental cement test methods, as appropriate. ## Biocompatibility A biocompatibility assessment was conducted in accordance with FDA Guidance Use of ISO 10993-1. The evaluation considered the nature and duration of device contact, material composition, predicate comparison, and risk management information. PacTemp Automix NE was determined to be biocompatible for its intended use and does not raise new questions of biological safety. ## Conclusions PacTemp Automix NE has the same intended use as the predicate device, UltraTemp Rez II (K211237). Both devices are non-eugenol temporary resin dental cements intended for provisional cementation procedures and utilize the same fundamental scientific technology. Bench testing demonstrated comparable performance characteristics. The information provided supports a determination that PacTemp Automix NE is substantially equivalent to the predicate device. Summary_PacTemp Automix NE_Rev.062426 Page 4 of 4 --- **Source:** [https://fda-staging.innolitics.com/device/K261937](https://fda-staging.innolitics.com/device/K261937) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com