Partial Flex® dental resin is a polymer base material used for the fabrication of partial removable dentures and prosthesis. Partial Flex is made from a resin of polypropylene that is designed and manufactured for injection molding. Partial Flex® is available in two shades as a granular material (so-called pellets) contained in an aluminum tube with 27 g or in a plastic bag of 250 g. In addition to high biocompatibility, Partial Flex® material features hypoallergenic properties, no risk of discoloration and the dental prosthesis made are unbreakable, which differentiates the from acrylic materials. The resin material is pigmented in one color and without pigment presentation: Light pink and Natural color (without pigment).

AI/ML Overview

The provided FDA 510(k) Clearance Letter for the device "Partial Flex" does not describe acceptance criteria, the study that proves the device meets acceptance criteria, or any details about AI/human reader studies.

The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device. It confirms that the device is a "Denture Relining, Repairing, Or Rebasing Resin" and lists some non-clinical performance tests conducted to show compliance with ISO standards (ISO 20795 and ISO 10993 for biocompatibility), but it does not provide specific acceptance values or the actual results of these tests beyond "passed the acceptance criteria" or "complies with the requirements."

Therefore, it's impossible to fill in the requested information based solely on the provided text. The prompt asks for details that are typically found in a clinical study report or a more detailed section of a 510(k) submission, neither of which is present in the provided clearance letter.

However, I can illustrate what a hypothetical response would look like if the information were available, using the structure of your request.

Hypothetical Response (Illustrative, as the provided document lacks the necessary data):

This document, an FDA 510(k) Clearance Letter, primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It details non-clinical performance testing but does not contain the specific acceptance criteria, detailed study results, or information pertaining to AI performance, human reader studies, or ground truth establishment that would be required to fully answer the prompt. The information below is hypothetical and structured as if the data were present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Hypothetical)	Reported Device Performance (Hypothetical)
Material Properties (per ISO 20795)	(Stated in document as "The material complies with the requirements" or "passed the acceptance criteria")
Ultimate Flexural Strength: > X MPa	Y MPa (Meets requirements)
Flexural Modulus: > A GPa	B GPa (Meets requirements)
Sorption: < C µg/mm²	D µg/mm² (Meets requirements)
Solubility: < E µg/mm²	F µg/mm² (Meets requirements)
Color Stability: Pass visual inspection after accelerated aging	Passed (Complies with requirements)
Freedom from Porosity: No visible pores greater than G mm	Complies with requirements
Biocompatibility (per ISO 10993)
Intracutaneous Injection Test: No significant irritation	Passed Acceptance Criteria
Kligman Maximization Test: Non-sensitizing	Passed Acceptance Criteria
L929 MEM Elution Test: Non-cytotoxic	Passed Acceptance Criteria
(If AI-related: Performance Metric 1, e.g., Accuracy)	(If AI-related: 95% CI of Metric 1, e.g., 92% (90-94%))
(If AI-related: Performance Metric 2, e.g., Sensitivity)	(If AI-related: 95% CI of Metric 2, e.g., 88% (85-91%))
(If AI-related: Performance Metric 3, e.g., Specificity)	(If AI-related: 95% CI of Metric 3, e.g., 95% (93-97%))

(Note: The provided document states "The material complies with the requirements" or "passed the acceptance criteria" without specifying the numerical values for the criteria themselves or the actual measured performance values. For example, under "Ultimate Flexural Strength," it only says "The material complies with the requirements." It does not give a specific threshold like "Ultimate Flexural Strength > 65 MPa" and then a result like "72 MPa".)

2. Sample Sizes and Data Provenance

The provided document describes non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests, nor does it refer to patient data (e.g., medical images, clinical outcomes) that would typically have provenance data.

Test Set Sample Size: Not applicable/Not specified in the provided document for human data or AI model evaluation. For bench tests, typical sample sizes are per ISO standards but not detailed here.
Data Provenance: Not applicable for the type of testing described (bench and biocompatibility). No mention of country of origin or retrospective/prospective data collection.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The provided document describes material testing and biocompatibility. It does not involve human readers, clinical data interpretation, or AI ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. No expert review or clinical test set adjudication is described in the provided document.

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

Not applicable. This is a material science device (dental resin), not a diagnostic imaging or AI-assisted interpretation device. No MRMC study was performed or is relevant to this device's 510(k) submission as described.

6. Standalone Algorithm Performance

Not applicable. This device is a physical dental resin, not an algorithm or software.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described in the document (material properties and biocompatibility) would be based on:

Established ISO Standards (e.g., ISO 20795 for dental base polymers, ISO 10993 for biocompatibility): These standards define the test methodologies and acceptable performance limits.
Laboratory Measurements and Biological Assays: Objective, quantitative measurements performed in a laboratory setting (e.g., measuring flexural strength, assessing cell viability, observing tissue reactions in animal models).

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this 510(k) submission.

8. Sample Size for the Training Set

Not applicable. This device is a manufactured resin, not an AI model requiring a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. This device is a manufactured resin, not an AI model.

Summary

FDA 510(k) Clearance Letter - Partial Flex

Page 1

June 3, 2025

Clemde Sa De Cv
Cabrera Francisco
General Manager
Mexico City, 07800
MEXICO

Re: K242897
Trade/Device Name: Partial Flex
Regulation Number: 21 CFR 872.3760
Regulation Name: Denture Relining, Repairing, Or Rebasing Resin.
Regulatory Class: Class II
Product Code: EBI, MQC
Dated: April 4, 2025
Received: May1, 2025

Dear Cabrera Francisco:

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.

June 3, 2025

Clemde Sa De Cv
Cabrera Francisco
General Manager
Mexico City, 07800
MEXICO

Dear Cabrera Francisco:

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K242897 - Cabrera Francisco 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (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 systems (QS) regulation (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-

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K242897 - Cabrera Francisco 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

Page 4

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Submission Number (if known)	K242897
Device Name	PARTIAL FLEX

Indications for Use (Describe)

Partial Flex® is indicated for the fabrication of partial or full removable dentures, as well oclusional

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

Partial Flex® 510(K) Premarket Notification

K 242897

Section 6 - 510(k) Summary

1. Submitter

APPLICANT: Av la Fortuna #136, Industrial,
México City 07800
Tel.: (+52) 55 3537 7103
Internet: www.clemde.com

CONTACT PERSON: Mariana Correa
Tel.:956 414 1295
E-mail: apcoconsultores@gmail.com

2. Device Name

Trade Names: Partial Flex
Common Name: Dental Resin
Classification Name: EBI Denture Relining, Repairing, or Rebasing Resin

3. Predicate Device

Partial Flex is substantially equivalent to the following predicate devices already cleared by the FDA:

Predicate Device	510(k) Number	510(k) Holder
TCS UNBREAKABLE	K053060	THERMOPLASTIC CONFORT SYSTEM

4. Description of the Device

4.1. Partial Flex

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4.2. Partial Flex Plastic bag

The resin material is pigmented in one color and without pigment presentation:

300116 Light pink
300118 Natural color (without pigment)

4.3. Partial Flex Aluminum tube

The resin material is pigmented in one color and without pigment presentation:

300073 Light pink
300079 Natural color (without pigment)

5. Indications for Use

5.1. Partial Flex

Partial Flex® is indicated for fabrication of partial or full removable dentures, as well oclusional splints or night guards.

6. Technological Characteristics

	NEW DEVICE	PREDICATE DEVICE
510(k) Submitter/Holder	CLEMDE	THERMOPLASTI CONFORT SYSTEM
Trade Name	Partial Flex	TCS UNBREAKABLE
510(k) Number	K242897	K053060
Material	Resin of polypropylene	polyamide
Shape	Pellets	Granulate – resin
Indications for use	Partial Flex® is indicated for fabrication of partial or full removable dentures, as well oclusional splints or night guards.	Fabrication and repair of removable dental prosthetic devices, such as full and partial dentures, orthodontic devices, occlusal splints, and guards.
Shape	Pellet	granular resin

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	NEW DEVICE	PREDICATE DEVICE
Color stability	The material complies with the requirements	-
Translucency	The material complies with the requirements	-
Freedom from porosity	The material complies with the requirements	-
Ultimate Flexural Strength	The material complies with the requirements	Physical testing meets standard for dental base polymers
Flexural modulus	The material complies with the requirements	Physical testing meets standard for dental base polymers
Maximum stress intensity factor for materials with improved impact resistance	The material complies with the requirements	Physical testing meets standard for dental base polymers
Total fracture work	The material complies with the requirements	Physical testing meets standard for dental base polymers
Sorption	The material complies with the requirements	Physical testing meets standard for dental base polymers
Solubility	The material complies with the requirements	Physical testing meets standard for dental base polymers

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7. Nonclinical Performance Testing

Partial Flex® has been tested in the following test modes:

Bench testing per Iso 20795.
Biocompatibility:
- INTRACUTANEOUS INJECTION TEST - per Iso 10993 passed the acceptence criteria
- KLIGMAN MAXIMIZATION TEST - per Iso 10993 passed the acceptence criteria
- L929 MEM ELUTION TEST - per Iso 10993 passed the acceptence criteria

The results of this nonclinical testing show that the PARTIAL FLEX is sufficient for its intended to used and is substantially equivalent to the legally marketed predicate device.

8. Substantial Equivalence Summary / Conclusion

Conclusion Based on available 510(k) information provided here in, Partial Flex is considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, design, and performance specifications.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.