(94 days)
No
The summary describes a standard dental implant system and its components, with no mention of AI or ML technology in the device description, intended use, or performance studies.
Yes.
The device is used to restore the patient's chewing function by providing support for artificial teeth, which is a therapeutic purpose.
No
The device description focuses on components for dental implants (fixtures, prosthetic components, surgical instruments) used for restorative procedures, not for identifying or diagnosing a condition.
No
The device description explicitly details physical components made of titanium, PEEK, and stainless steel, including implants, prosthetic components, and surgical instruments. There is no mention of software as the primary or sole component.
Based on the provided information, the Paltop Dental Implant System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is used for surgical and restorative applications within the bone of the jaw to support prosthetic devices and restore chewing function. This is a direct intervention on the patient's body.
- Device Description: The description details implants, prosthetic components, and surgical instruments, all of which are physical devices used in a surgical and restorative procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The Paltop Dental Implant System is a medical device used inside the body for treatment and restoration.
N/A
Intended Use / Indications for Use
The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Product codes
DZE, NHA
Device Description
Paltop Dental Sterile Accessories are packaged is a standard, commonly used in the dental market, blister packaging made out of radiation resistant transparent polyethylene (PET) sealed with medical grade tyvek sheet. The accessories will be sterilized using gamma irradiation.
Paltop Prosthetic Components include a variety of abutments, healing cups and impression coping components having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant. The Paltop prosthetic components, as other available in the market dental prosthetics are dental components composed either of titanium (Ti6AL4V ELI) or peek.
Paltop surgical instruments consist of a variety of instruments required for dental surgical and reconstructive procedures including primary and final drills, Key set and adapters. The Paltop surgical instruments, as other available in the market surgical instruments, are composed of stainless still or TI6AL4V ELI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw
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
Non Clinical Tests: Risk analysis process was conducted to assess the impact of the modification of the device. Gamma radiation sterilization and shelf life validation were performed. Other performance testing and validations conducted for Paltop's original components (Fatigue, steam sterilization) were shown to be applicable to the modified device. Bench testing and validations demonstrates that Paltop dental sterile accessories are substantially equivalent to predicate devices and do not raise new issues of safety or effectiveness.
Clinical Tests: N/A
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside a circle on the left. To the right of the tooth is the word "PALTOP" in a bold, sans-serif font. There is a superscripted "R" next to the "P" on the right.
510(k) SUMMARY
510(k) Number K131451
| Applicants Name: | Paltop Advanced Dental Solutions Ltd.
Hashita 5
Industrial Park Caesarea 30889, Israel
T +972 4 6271711
F +972 4 6275363 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tal Hammer-Topaz
Quality, Regulatory & Clinical Manager
Paltop Advanced Dental Solutions Ltd.
Hashita 5
Industrial Park Caesarea 30889, Israel
T +972 5 23 520050
F +972 4 6275363
Email: tal@paltopdental.com |
| Date Prepared: | May 13th, 2013 |
| Type of Submission: | Special 510(k) |
| Trade Name: | Paltop Dental Sterile Accessories |
| Classification Name: | Implant, Endosseous, Root-form |
| Common usual name: Dental Implant Accessories | |
| Medical Specialty: | Dental |
| Product Code: | DZE, NHA |
| Device Class: | Class II |
| Regulation Number: | 872.3640 |
| Review Panel: | Dental Device Panel |
| Predicate Device: | |
Paltop Dental Implant System (Paltop Advanced Dental Solutions Ltd.) cleared
under K112795; product code DZE, NHA (Implant, Endosseous, Root-Form).
AUG 2 2 2013
: ... "
510(k) Premarket Notification
.
page.6-3
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Image /page/1/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth icon on the left, followed by the word "PALTOP" in a modern, geometric font. A small registration mark is visible to the right of the word.
Intended Use / Indication for Use:
The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Description:
Paltop Dental Sterile Accessories are packaged is a standard, commonly used in the dental market, blister packaging made out of radiation resistant transparent polyethylene (PET) sealed with medical grade tyvek sheet. The accessories will be sterilized using gamma irradiation.
Paltop Prosthetic Components include a variety of abutments, healing cups and impression coping components having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant. The Paltop prosthetic components, as other available in the market dental prosthetics are dental components composed either of titanium (Ti6AL4V ELI) or peek.
Paltop surgical instruments consist of a variety of instruments required for dentalsurgical and reconstructive procedures including primary and final drills, Key set and adapters. The Paltop surgical instruments, as other available in the market surgical instruments, are composed of stainless still or TI6AL4V ELI.
Substantial Equivalence:
The modification which is the subject of this special 510(k) notification is change of the packaging only: Paltop modified devices will be provided in a sterile blister package. The modification does not alter the intended use, technological
510(k) Premarket Notification
2
Image /page/2/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth icon on the left, followed by the word "PALTOP" in a bold, sans-serif font. A small registration mark is visible to the right of the word "PALTOP".
characteristics and mode of operation of the device. Based on the verification and validation testing results and the analysis of the similarities and differences presented in this submission, Paltop Advanced Dental Solutions Ltd believes that the Paltop dental sterile accessories are substantially equivalent to their predicates (K112795) without raising new issues of safety or effectiveness.
Non Clinical Tests:
Risk analysis process was conducted to assess the impact of the modification of the device. Gamma radiation sterilization and shelf life validation were performed. Other performance testing and validations conducted for Paltop's original components (Fatigue, steam sterilization) were shown to be applicable to the modified device. Bench testing and validations demonstrates that Paltop dental sterile accessories are substantially equivalent to predicate devices and do not raise new issues of safety or effectiveness.
Clinical Tests:
N/A
Summary:
The evaluation of Paltop Dental Sterile Accessories do not raise any additional concerns regarding safety and effectiveness of the device and therefore Paltop Advanced Dental Solutions Ltd. believes it may be considered as substantially equivalent to its predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2013
Palton Advanced Dental Solutions, Limited Mr. Tal Hamer-Topaz Quality, Regulatory & Clinical Manager 5 Hashita Street Industrial Park CAESAREA, ISRAEL 30889
Re: K131451
Trade/Device Name: PALTOP Dental Sterile Accessories -Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 28, 2013 Received: July 31, 2013
Dear Mr. Hamer-Topaz:
We have reviewed your Section 510(k) promarket 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 prodicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered prof they as may a cordance with the provisions of the Federal Food. Drug, and Cosmetic Act (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. The general controls provisions of the Act include requirements for annual registration, listing of I he general connous provisions and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warrantics. 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 if your device is blackned (boo worls). Existing major regulations affecting your device can be may be sabyer to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Mr. Hamer-Topaz
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/4/Picture/6 description: The image shows the name "Mary S. Runner - S" in a bold, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The letters are black against a white background, creating a high contrast.
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
UPALTOP
Indications for Use
510(k) Number (if known): K13145)
Device Name:
PALTOP Dental Sterile Accessories
Indications for Use:
The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
AND/OR Over-The-Counter Use __________________________________________________________________________________________________________________________________________________ Prescription Use V (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IFNEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen -S 2013.08.22 08:26:44 -04'00
(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices
િર્સિક 510(k) Number. F
←
510(k) Premarket Notification
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