(60 days)
Not Found
No
The summary describes a thermoplastic material used for manufacturing dental prostheses and CAD/CAM blocks, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a material used for the manufacture of dental prostheses (dentures, crowns, frameworks), which are replacement parts rather than therapeutic interventions to treat or prevent disease.
No
The device description and intended use indicate that 'PF KEEP / CAD CAM BLOCK' is a thermoplastic material used for the manufacture of dental prostheses (dentures, crowns, frameworks). There is no mention of it being used to diagnose a medical condition or ailment.
No
The device description clearly states it is a thermoplastic material available as granular material or blocks, indicating a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the manufacture of dental prostheses (dentures, crowns, bridges, etc.). This is a device used in the mouth for structural and functional purposes, not for testing biological samples outside the body to diagnose or monitor a medical condition.
- Device Description: The description confirms it's a thermoplastic material used for manufacturing dental devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a material used to create a physical structure for dental restoration.
N/A
Intended Use / Indications for Use
PF KEEP / CAD CAM BLOCK IS A THERMO PLASTIC MATERIAL. THEY ARE INTENDED TO BE USED FOR THE MAANUFACTURE OF: I) FULL AND PARTIAL REMOVABLE DENTURES AND IMPLANT OVERDENTURES II)COPINGS, SUBSTRUCTURES (CEMENTED OR UNCEMENTED), FRAMEWORKS FOR PERMANENT AND TRANSITIONAL ANTERIOR OR POSTERIOR CROWNS AND BRIDGEWORKS.
Product codes (comma separated list FDA assigned to the subject device)
EBI, EBG, EBF
Device Description
PF KEEP is a thermoplastic polymer, made from the polymer peek, is available as a granular material (so-called pellets) contained in plastic box with 45 g. that are used for manufacture of removable dental protheses. In case of CAD CAM PEEK BLOCK is for used with CAD CAM techniques. The material is provided nonsterile, without any accessories, and is a single use.
The CAD CAM PEEK BLOCK are provided in different sizes.
900033 CAD CAM PEEK BLOCK 14 MM
900034 CAD CAM PEEK BLOCK 16 MM
900035 CAD CAM PEEK BLOCK 18 MM
900036 CAD CAM PEEK BLOCK 20 MM
900037 CAD CAM PEEK BLOCK 22 MM
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing per Iso 20795.
Biocompatibility per Iso 10993
The results of this nonclinical testing show that the PF KEEP/ CAD CAM PEEK BLOCK is sufficient for its intended to used and is substantially equivalent to the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
November 27, 2023
Clemde Sa De Cv Francisco Cabrera General Manager Av La Fortuna 136 Mexico City, 07800 MEXICO
Re: K233171
Trade/Device Name: PF Keep; Cad Cam Keep Block Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, EBG, EBF Dated: September 25, 2023 Received: September 28, 2023
Dear Francisco Cabrera:
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.
1
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 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-reportingcombination-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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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
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
Submission Number (if known)
Device Name
PF KEEP:
CAD CAM KEEP BLOCK
Indications for Use (Describe)
PF KEEP / CAD CAM BLOCK IS A THERMO PLASTIC MATERIAL. THEY ARE INTENDED TO BE USED FOR THE MAANUFACTURE OF: I) FULL AND PARTIAL REMOVABLE DENTURES AND IMPLANT OVERDENTURES II)COPINGS, SUBSTRUCTURES (CEMENTED OR UNCEMENTED), FRAMEWORKS FOR PERMANENT AND TRANSITIONAL ANTERIOR OR POSTERIOR CROWNS AND BRIDGEWORKS.
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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4
PF KEEP ® 510(K) Premarket Notification
Image /page/4/Picture/1 description: The image shows the logo for CLEMDE. The logo consists of a circular icon with a stylized "C" formed by interconnected dots on the left, followed by the word "CLEMDE" in bold, sans-serif font. The entire logo is in black and set against a white background.
K 233171
Section 6 - 510(k) Summary
1. Submitter
SUBMITTER: CLEMDE S.A. DE C.V.
Av la Fortuna #136, Industrial, México City 07800 Tel.: (+52) 55 3537 7103 Internet: www.clemde.com Date prepared: September 25, 2023
CONTACT PERSON: Mariana Correa Tel.:956 414 1295 E-mail: apcoconsultores@gmail.com
2. Device Name
PF KEEP - CAD CAM PEEK BLOCK Trade Names:
Common Name: Dental Resin
Classification Name: EBI. Denture Relining, Repairing, Rebasing Resin.
3. Predicate Device
PF KEEP ® and CAD CAM PEEK BLOCK are substantially equivalent to the following predicate device already cleared by the FDA:
| 510 K
| Number | Predicate Device | Manufacture |
|---|---|---|
| K160918 | Juvora TM dental disc | Juvora Ltd |
5
Image /page/5/Picture/1 description: The image shows the logo for CLEMDE. The logo consists of a circular icon to the left and the word "CLEMDE" in bold, sans-serif font to the right. The circular icon contains a stylized "C" shape formed by a series of smaller circles or dots arranged in a circular pattern. The word "CLEMDE" is written in all capital letters and is positioned directly to the right of the icon.
4. Description of the Device
4.1. PF KEEP
PF KEEP is a thermoplastic polymer, made from the polymer peek, is available as a granular material (so-called pellets) contained in plastic box with 45 g. that are used for manufacture of removable dental protheses. In case of CAD CAM PEEK BLOCK is for used with CAD CAM techniques. The material is provided nonsterile, without any accessories, and is a single use.
The CAD CAM PEEK BLOCK are provided in different sizes.
900033 CAD CAM PEEK BLOCK 14 MM 900034 CAD CAM PEEK BLOCK 16 MM 900035 CAD CAM PEEK BLOCK 18 MM 900036 CAD CAM PEEK BLOCK 20 MM 900037 CAD CAM PEEK BLOCK 22 MM
5. Indications for Use
5.1. PF KEEP / CAD CAM PEEK BLOCK
PF KEEP / CAD CAM PEEK BLOCK is a thermoplastic material. they are intended to be used for manufacture of:
- I) Full and partial removable dentures and implant overdentures.
- II) Copings, substructures (cemented or uncemented), frameworks for permanent and transitional anterior or posterior crowns and bridgeworks.
6. Technological Characteristics
| NEW DEVICE | PREDICATE DEVICE | |
|---|---|---|
| 510(k) | ||
| Submit-ter/ | ||
| Holder | CLEMDE SA DE CV | JUVORA, Ltd |
| Trade | ||
| Name | PF KEEP | |
| CAD CAM PEEK BLOCK | Juvora TM dental disc | |
| 510(k) | ||
| Number | - | K160918 |
| Material | PEEK | PEEK |
| Shape | Granulate - Pellets | |
| Disc | Disc | |
| Indications | ||
| for use | PF PEEK is a thermoplastic MATERIAL. They are intended to be used for the manufacture of: | |
| I) full and partial removable dentures and | ||
| implant overdentures. | The Juvora Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of: | |
| i) full and partial removable dentures | ||
| and implant overdentures. |
6
Image /page/6/Picture/1 description: The image shows the word "CLEMDE" in a bold, sans-serif font. To the left of the word is a circular graphic with a "C" shape formed by small circles. The graphic is black and white and appears to be a logo. The overall impression is of a company logo or brand name.
| | II) copings, substructures
(Cemented or uncemented), frameworks for
permanent and
transitional anterior
or posterior crowns
and bridgework. | ii) copings, substructures
(Cemented or uncemented), frameworks
for permanent and
transitional anterior
or posterior crowns
and bridgework. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ultimate
Flexural
Strength | 162 Mpa | 165 MPa |
| Flexural
modulus | 3530 MPa | 3995 MPa |
| Stress
Intensity
Factor | 6.81 MPa m2 | - |
| Total fracture
work | 10846 J/m² | -- |
| Water sorption | 5 µg/mm3 | 5 µg/mm3 |
| Solubility | 0.04 µg/mm3 | -- |
7
PF KEEP ® 510(K) Premarket Notification
Image /page/7/Picture/1 description: The image shows the logo for CLEMDE. The logo consists of a circular icon on the left and the word "CLEMDE" in bold, sans-serif font on the right. The icon features a stylized "C" surrounded by small squares within a circle, resembling a bearing or gear. The overall design is clean and modern, with a focus on simplicity and readability.
7. Nonclinical Performance Data
PF KEEP / CAD CAM KEEP BLOCK has been tested in the following test modes:
- -Bench testing per Iso 20795.
- -Biocompatibility per Iso 10993
The results of this nonclinical testing show that the PF KEEP/ CAD CAM PEEK BLOCK is sufficient for its intended to used and is substantially equivalent to the legally marketed predicate device.
8. Substantial Equivalence Summary / Conclusion
Based on the available information provided, PF KEEP ® and CAD CAM PEEK BLOCK are considered substantial equivalent to the predicate devices in terms of indications for use, material, technology, and performance specifications.