(330 days)
Not Found
No
The summary describes a physical implant and does not mention any software, image processing, or AI/ML terms.
No
The device, a Zygomatic implant, is described as being implanted to provide support for dental prostheses. It is a structural component rather than a device that directly treats a disease or condition or restores function through a therapeutic action.
No
The device is an implant intended to provide support for dental prostheses, not to diagnose a condition or disease.
No
The device is a physical implant intended for surgical placement, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the device is a "Zygomatic implant" intended to be "implanted in the upper jaw arch" to "provide support for fixed or removable dental prostheses." This is a surgically implanted device used for structural support, not for testing biological samples.
The information provided about the device's intended use, description, and performance studies all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The Zygomatic implant is intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with fully or partially edentulous maxillae.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
The Zygomatic implant is intended to be implanted in the upper jay arch to provide support for fixed or removable dental prostheses in patients with fully or partially edentulous maxillae.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper jaw arch
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)
Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.
Engineering Studies: Fatigue studies were conducted as per FDA Class II Special Controls Guidance Document and ISO standard 14801: 2007(E). Testing revealed a stable screw joint at the highest forces tested.
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
K0933662
510(K) PREMARKET NOTIFICATION SUMMARY
Name/Address of Submitter: Southern Implants, Inc. 5 Holland, Bldg. 209 Irvine, CA 92618
OCT 1 4 2010
Establishment Registration Number: 3003845138
Contact Person: Michael A. Kehoe Phone: (866) 700-2100 x 225 Fax: (949) 273-8508
Date Summary Prepared: October 20, 2009
Device Classification Name: Endosseous Implant and Accessories
Device Classification Regulation Number: 21 CFR 872.3640
Device Regulatory Status: Class II Special Controls
Trade Name: Zygomatic Implant
Purpose: The purpose of this 510(k) is to include additional implants and accessories in the Southern Implant System that did not fall within the size range and design shapes identified in prior 510(k) submissions.
Performance Standards: FDA has not established a performance standard applicable to endosseous implants and their accessories. The materials in Southern's Zygomatic Implant System meet applicable voluntary standards. Southern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade IV Titanium.
K970499 Branemark System Zygomatic Implant; K070182 Nobel Biocare Zygoma Predicate Devices: Implant
Device Description and Intended Use: The Zygomatic implant is intended to be implanted in the upper jay arch to provide support for fixed or removable dental prostheses in patients with fully or partially edentulous maxillae.
Sterilization Methods Used: Sterilization of these implants will be achieved using Co60 irradiation, with a minimum dose of 25.0 kGy (2.5 m rads), creating a Sterility Assurance Level of 10 . Validation of sterilization will be done as specified by the Association for the Advancement of Medical Instrumentation (AAMI). Standards utilized include:
180 11137 Sterilization of Health Care Products - Requirements for validation and routine control - Radiation sterilization
150 11137-2 Sterilization of Medical Devices - Microbial Methods - Part 2: Tests of sterility performed in the validation of a sterilization process
Sterilization of Health Care Products - Radiation Sterilization - substantiation of 25kGy as a ISO 13409 sterilization dose for small or infrequent production batches.
Packaging Method: Please note that our implants are packaged the same as our existing line of dental implants that are cleared NSI hexed and non-hexed Implant Systems noted above as predicate devices. Implants are placed into plastic tubing (PT6.1) and capped on both ends. The plastic tube is then heat sealed in a blister pack consisting of a transparent film (P.E.T.) and a porous sheet material backing (Tyvek 1073B). This blister pack is considered the primary pack (that which provides the microbial barrier) for the implants. The Tyvek is coated with an adhesive. A sterilization indicator sticker is placed on the blister with its contents are then enclosed in a clear plastic box and sent for sterilization.
1
| Packaging Validation: All Southern Implants packaging is validated following these standards: | ||
|---|---|---|
| ASTM D 4169-08 | Standard Practice for Performance Testing of Shipping Containers and Systems | |
| ASTM F 88-00 | Standard Test Method for Seal strength of Flexible Barrier Materials | |
| ASTM F 1929-98 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye | |
| Penetration | ||
| ASTM F 1980-07 | Standard Guide for Accelerated Aging of Sterile Medical Device Packages | |
| EN 552 | Sterilization of medical devise – Validation and routine control of sterilization by | |
| irradiation | ||
| EN226 | Sterilization of medical devices - Requirements for medical devices to be labeled "Sterile" | |
| EN 868-1:1997 | Packaging materials and systems for medical devices with are to be sterilized: Part 1 | |
| General requirements and test methods | ||
| EN 868-5:1999 | Packaging materials and systems for medical devices which are to be sterilized - Part 5: | |
| Heat and self-sealable pouches and reels of paper and plastic film construction - | ||
| Requirements and test methods | ||
| EN 868-9: 2000 | Packaging materials and systems for medical devices which are to be sterilized - Part 9: | |
| Uncoated non-woven materials of polyolefines suitable for use as packaging of medical | ||
| devices which are to be terminally sterilized - Requirements and test methods. | ||
| EN 868-10:2000 | Packaging materials and systems for medical devices which are to be sterilized - Part 10: | |
| Adhesive coated nonwoven material of polyolefines for use in the manufacture of heat | ||
| sealable pouches, reels and lids - Requirement s and test methods | ||
| ISO 11607 | Packaging for terminally sterilized medical devices |
Technological Characteristics: The physical properties and designs of the additional implants and accessories in the NSI Endosseous Dental Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.
Surface Modifications: Please note that this is the same surface modification method currently used with our existing line of dental implants that are cleared NSI hexed and non-hexed Implant Systems noted above as predicate devices. The surface of our implant is blasted using 100 micron alumina (Al2O2) particles. Alumina is a highly biocompatible material and hence if any particles remain embedded in the surface, they will not pose a complication. The other measure taken to reduce the potential of embeddiment is to blast with relatively low pressure. If the indentations caused are significantly smaller than the size of the particles tend to not adhere to the surface. (Our S = 1.43 microns is a fraction of the particle size of 110 microns). Each and every implant is visually inspected under a microscope after surface enhancement as a matter of manufacturing protocol. In addition to visual inspection, a sample implant is sent for SEM testing four times a year for evaluation of the surface as well.
Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.
Brief Discussion of Engineering Studies: Fatigue studies were conducted as per FDA Class II Special Controls Guidance Document and ISO standard 14801: 2007(E). Testing revealed a stable screw joint at the highest forces tested. See enclosed study.
Conclusions Drawn: The Southern Zygomatic Implant System has the same intended use as, and technological characteristics similar to, the legally marketed predicate devices. Any differences in the technological characteristics did not raise new issues of safety or effectiveness.
2
▲ ﺘﻪ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ
| | Southern 55°angle
corrected tapered implant | Nobel Biocare Zygomatic
45° Implant |
|----------------------------------------------------------------------|------------------------------------------------|-----------------------------------------|
| Specification for material | ASTM Grade IV titanium | Titanium |
| Exterior geometry | Threaded | Threaded |
| Implant width at
restorative platform (mm) | 4.05 | 4.0 |
| Implant lengths (mm) | 35, 37.5, 40, 42.5, 45,
47.5, 50, 52.5, 55 | 30, 35, 40, 42.5, 45, 47.5,
50, 52.5 |
| Maximum diameter (mm) | 4.05 | 4.1 |
| Apical end diameter (mm) | 3.8 | 2.8 |
| Hex width x height (mm) | 2.7 x 0.7 | 2.7 x 0.7 |
| Internal screw access
width (mm) | 2.0 | 2.0 |
| Angle of screw access
opening relative to long
axis of implant | 55° | 45° |
Comparison of Properties and Features of Southern's 4.0 mm 55° angle-corrected implant to Nobel Biocare's Zygomatic 45° implant
Indication for Use: The Zygomatic implant is intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with fully or partially with fully or partially edentulous maxillae.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael A. Kehoe President and Chief Executive Officer Southern Implants, Incorporated 5 Holland Building 209 Irvine, California 92618
OCT 1 4 2010
Re: K093562
Trade/Device Name: Zygomatic Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 23, 2010 Received: September 24, 2010
Dear Mr. Kehoe:
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. 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.
4
Page 2- Mr. Kehoe
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm_for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number: K093562
OCT 1 4 2010
Device Name: Zygomatic Implant System
.
Indication for Use: The Zygomatic implant is intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with partially or fully edentulous maxillae.
Concurrence of CDRH Office of Device Evaluation
Prescription Use (Per 21 CFR801.109)
OR
Over-the-counter Use
Susan Puanor
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division Control, Denta. Devices
510(k) Number: K093562