(79 days)
Not Found
No
The summary describes a physical dental implant and its components, with no mention of software, algorithms, or any terms related to AI/ML.
No
A dental implant is a device surgically placed in the jawbone to support dental prostheses, not to provide therapy or treatment for a disease or condition. Its primary function is structural support.
No
Explanation: The device description states its use is to provide support for prosthetic devices (dental implants), not to diagnose a condition.
No
The device description explicitly states it is an "endosseous dental implant" consisting of physical components (implant, healing cap, attachments) that are surgically placed. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use as an endosseous dental implant to provide support for prosthetic devices. This is a surgical device implanted directly into the body.
- Device Description: The description details a physical implant and its components, designed for surgical placement in bone.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) to provide information about a person's health, condition, or disease. IVDs are typically used in laboratories or point-of-care settings for diagnostic purposes.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Pitt-Easy Dental Implant System is an endosseous dental implant that is intended to be surgically placed in bone of the upper or lower jaw arches to provide support for dental prosthesis. The Pitt-Easy Implant consists of two component parts: the implant (root component) and a threaded healing cap. In addition, attachments that are screw-retained, such as restorative abutments, are available for attachment to the root component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper or lower jaw arches
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)
Not Found
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
§ 872.3640 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
KOS 3297
Section III - 510(k) Summary
Submitter:
JAN 2 8 2009
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone . (714) 516-7488 - Facsimile Wendy Garman - Contact Person
Date Summary Prepared:
November 2008
Device Name:
- Trade Name Pitt-Easy Dental Implant System .
- . Common Name - Endosseus Root-Form Implant
- Classification Name Implant, Endosseous Dental, per 21 CFR § 872.3640 .
Devices for Which Substantial Equivalence is Claimed:
- Sybron Implant Solutions GmbH, Pitt-Easy™ Dental Implant System, K053242 .
Device Description:
The Pitt-Easy Dental Implant System is an endosseous dental implant that is intended to be surgically placed in bone of the upper or lower jaw arches to provide support for dental prosthesis. The Pitt-Easy Implant consists of two component parts: the implant (root component) and a threaded healing cap. In addition, attachments that are screw-retained, such as restorative abutments, are available for attachment to the root component.
Intended Use of the Device:
The Pitt-Easy Dental Implant System is indicated for use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
Substantial Equivalence:
There is no change in composition, design or intended use for the proposed device compared to its predicate and it is considered to be substantially equivalent. The only change being proposed is adding a new contraindication to the Directions for Use (DFU).. The new contraindication states that Pitt-Easy implants of 3.25mm diameter are not suitable for single tooth replacement in the posterior region.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sybron Implant Solutions GmbH C/o Ms. Wendy Garman Director, Regulatory Affairs Sybron Dental Specialties, Incorporation 1717 West Collins Avenue Orange, California 92867
JAN 2 8 2009
Re: K083297
Trade/Device Name: Pitt-Easy Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 19, 2009 Received: January 23, 2009
Dear Ms. Garman.
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 (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 devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Ms. Garman
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Anthony D. mator
Ginette V. Michaud, M.D.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Labeling Change Being Effected Sybron Dental Specialties, Inc.
Indications for Use
510(k) Number (if known):
Device Name: Pitt-Easy Dental Implant System
Indications For Use:
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
Contraindications for the Pitt-Easy 3.25 mm diameter implants are being added to the Directions for Use (DFU).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Chase
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
1
KOS 3297
´í 10(k) Number: ·