Transcend Bulk Fill Flowable Composite
Device Facts
| Record ID | K262228 |
|---|---|
| Device Name | Transcend Bulk Fill Flowable Composite |
| Applicant | Ultradent Products, Inc. |
| Product Code | EBF · Dental |
| Decision Date | Jul 1, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric, 3rd-Party Reviewed |
Indications for Use
Transcend™ Bulk-Fill flowable composite is used for: - Direct and indirect restorations in both the anterior and posterior regions - Fabrication of orthodontic attachments for aligners and bonding of lingual retainers
Device Story
Light-cured, radiopaque, methacrylate-based flowable bulk fill composite; used by trained dental professionals in clinical settings. Input: material applied to tooth structure or orthodontic attachment templates. Operation: light-curing initiates polymerization; material acts as restorative or bonding agent. Output: hardened dental restoration or orthodontic attachment. Benefits: low shrinkage stress, high wear resistance, 4 mm depth of cure (ISO 4049), and radiopacity (2.3 mm aluminum equivalent) for clinical visibility. Not for use on occlusal surfaces; requires packable composite as final occlusal layer. Clinical decision-making: provider selects material based on restorative or orthodontic needs; material adapts to tooth structure/templates to restore function or secure appliances.
Clinical Evidence
Bench testing only. No clinical data. Testing included ISO 4049 performance metrics (compressive strength, Knoop hardness, depth of cure, water sorption/solubility, flexural strength, color stability, shrinkage volume, radiopacity), biocompatibility (ISO 10993-1), and simulated use testing (restoration/orthodontic procedures, adaptability, removal). All criteria met.
Technological Characteristics
Light-cured, methacrylate-based resin (BisGMA, BisEMA(2), diurethane dimethacrylate, IBMA). Fillers: glass/silinated glass (56% by mass, 47% by volume, ~1 μm particle size). Radiopaque (2.3 mm Al equivalent). Depth of cure: 4 mm (ISO 4049). Non-sterile. Shelf life: 48 months.
Indications for Use
Indicated for patients of all ages requiring direct/indirect dental restorations in anterior/posterior regions, fabrication of orthodontic attachments for aligners, and bonding of lingual retainers. Contraindicated in patients with known sensitivities to methacrylates or other resins.
Regulatory Classification
Identification
Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
Predicate Devices
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG
ADMINISTRATION
July 1, 2026
Ultradent Products, Inc.
% Dave Yungvirt
CEO
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson, Nevada 89014
Re: K262228
Trade/Device Name: Transcend Bulk Fill Flowable Composite
Regulation Number: 21 CFR 872.3690
Regulation Name: Tooth shade resin material
Regulatory Class: Class II
Product Code: EBF, DYH
Dated: June 29, 2026
Received: June 30, 2026
Dear Dave Yungvirt:
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
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K262228 - Dave Yungvirt
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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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 21 CFR 820.70) and document changes and approvals in the Medical Device File (21 CFR 820.181).
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
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K262228 - Dave Yungvirt
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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
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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: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K262228
Device Name
Transcend Bulk-Fill Flowable Composite
Indications for Use (Describe)
Transcend™ Bulk-Fill flowable composite is used for:
- Direct and indirect restorations in both the anterior and posterior regions
- Fabrication of orthodontic attachments for aligners and bonding of lingual retainers
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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EF
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K262228
# 510(k) Summary
Substantial Equivalence Summary — Public Document (21 CFR 807.92)
## 1. Applicant / Submitter Information
| Field | Entry |
| --- | --- |
| Date | 29 June 2026 |
| Applicant Name | Ultradent Products, Inc. |
| Applicant Address | 505 West Ultradent Drive, South Jordan, UT 84095 |
| Contact Person | Ruth Gardner |
## 2. Device Information
| Field | Entry |
| --- | --- |
| Device Trade Name | Transcend Bulk Fill Flowable Composite |
| Common / Generic Name | Tooth shade resin material |
| Classification | Class II |
| Product Code | EBF DYH |
| Regulation Number | 21 CFR 872.3690 21 CFR 872.3750 |
## 3. Indications for Use
Transcend™ Bulk Fill flowable composite is used for:
- Direct and indirect restorations in both the anterior and posterior regions
- Fabrication of orthodontic attachments for aligners and bonding of lingual retainers
## 4. Device Description
Transcend™ Bulk Fill flowable composite is a light-cured, radiopaque, methacrylate-based flowable bulk fill composite. Transcend Bulk Fill flowable composite is available in the Universal Body shade based on an average dentin shade designed to take on the shade of the surrounding tooth structure. Do not use Transcend™ Bulk Fill flowable composite as the occlusal surface of a restoration. It is recommended to use a packable composite as the final layer when restoring an occlusal surface. The chemistry possesses low shrinkage stress and high wear resistance. Per ISO 4049 testing, the composite has a 4 mm depth of cure. Per testing in a tooth-colored mold, the composite has a 7 mm depth of cure. Transcend Bulk Fill flowable composite has a radiopacity value of 2.3 mm of aluminum. Aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material having a radiopacity equivalent to 1 mm of aluminum has a radiopacity equivalent to that of dentin and 2 mm of aluminum is equivalent to enamel. Transcend Bulk Fill
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flowable composite is a 56% filled by mass and 47% filled by volume thixotropic bulk fill composite with an average particle size of ~1 μm.
Transcend™ Bulk Fill flowable composite is intended to be used by trained dental professionals and can be used on patients of all ages and conditions requiring the indicated restoration and orthodontic attachment procedures other than those with known sensitivities to methacrylates or other resins. Any restrictions regarding patient populations can be found below in the Contraindications section.
# 5. Predicate Device(s)
| Device Name | 510(k) # | Applicant | Clearance Date | Regulation |
| --- | --- | --- | --- | --- |
| Transcend | K201795 | Ultradent Products, Inc | 9/28/2020 | 21 CFR 872.3690 |
| AlignerFlow LC | K231817 | Voco GmbH | 12/01/2023 | 21 CFR 872.3750 |
# 6. Comparison to Predicate
| Characteristic | Subject Device | Primary Predicate | Secondary Predicate | Same / Different |
| --- | --- | --- | --- | --- |
| Intended Use | Dental restorative composite material | Dental restorative composite material | Dental composite for orthodontic applications | Same |
| Indications for Use | Transcend™ Bulk Fill flowable composite is used for: - Direct and indirect restorations in both the anterior and posterior regions - Fabrication of orthodontic attachments for aligners and bonding of lingual retainers | Transcend universal composite is used for direct and indirect restorations in both the anterior and posterior regions. | -Retention of aligners by fabrication of aligner attachments -Bonding of lingual retainers -Occlusal build-ups | Similar Transcend™ Bulk Fill Flowable Composite shares the same intended use as both predicate devices; however, it does not include indications for occlusal build-ups. |
| Technology / Design Principle | - Light-cured methacrylate-based resin - Methacrylates/BisGMA, BisEMA(2), diurethane dimethacrylate, IBMA resin with glass/silinated glass fillers. | - Light-cured methacrylate-based resin - Methacrylate/dimethacrylate resin with silica/silanated silica fillers. - 24 month shelf life | - Light-cured methacrylate-based resin - Barium aluminium borosilicate glass, silicon dioxide, DDDMA, BisGMA, TEGDMA, BisEMA, fumed silica, | Similar — same fundamental technology (light-cured methacrylate-based resin); differences in formulation, |
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| | - 48 month shelf-life | | - initiators, stabilisers, pigments; contains methacrylate and BHT. - Shelf-life not found in official documentation | filler, and shelf-life are present but do not raise new questions of safety or effectiveness and were evaluated through bench testing |
| --- | --- | --- | --- | --- |
| Sterility | Non-sterile | Non-sterile | Non-sterile | Same |
## 7. Summary of Testing
| Test Category | Method / Standard | Conclusion |
| --- | --- | --- |
| Bench Performance Testing | - ISO 4049 - Compressive Strength - Knoop Hardness - Depth of Cure - Water Sorption - Water Solubility - Resin Compatibility - Appearance - Light Sensitivity - Shrinkage Volume - Radio-opacity - Flexural Strength - Color Stability - Fill Volume Range - Expression Testing - Adaptability to Orthodontic attachment templates - Simulated Use: Removal from tooth - Simulated Use: Restoration procedures and orthodontic attachment procedures | Passed — all criteria met |
| Biocompatibility (ISO 10993) | ISO 10993-1:2018 | Biocompatible — all endpoints addressed |
| Sterilization Validation (if applicable) | Not Applicable (non-sterile device) | N/A |
| Shelf Life (if applicable) | Stability testing per internal protocols | 48 Months |
| Software V&V (if applicable) | Not Applicable | N/A |
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| Electrical Safety/EMC (if applicable) | Not Applicable | N/A |
| --- | --- | --- |
### 8. Substantial Equivalence Conclusion
Transcend™ Bulk Fill Flowable Composite has the same intended use as Transcend™ Composite (K201795) and AlignerFlow LC (K231817). The primary predicate, Transcend™ Composite (K201795), supports the restorative indications and material characteristics of the subject device. The secondary predicate, AlignerFlow LC (K231817), which is classified under product code DYH, supports orthodontic applications, including fabrication of aligner attachments. The subject device shares the same fundamental technological characteristics as the predicate devices, namely the use of a light-cured, methacrylate-based composite system. Differences in formulation, filler, and shelf-life are present; while these do not raise new questions of safety or effectiveness and were evaluated through bench testing, the technological characteristics of the subject device are not identical to those of the predicate devices. These variances do not affect the substantial equivalence determination but are noted here for completeness and traceability of review documentation. Performance testing and biocompatibility data demonstrate that the device is as safe and effective as the predicate devices. Therefore, Transcend™ Bulk Fill Flowable Composite is substantially equivalent to the identified predicate devices.
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