(242 days)
Not Found
No
The summary describes a standard dental implant system with mechanical components and materials testing, with no mention of software, algorithms, or AI/ML terms.
Yes
The device is used to support prosthetic devices like artificial teeth, crowns, bridges, and overdentures, which are meant to restore or replace missing or damaged anatomical structures, thereby providing therapeutic benefits to the patient.
No
The device description indicates it is a surgical implant system (endosseous dental implants, abutments, screws, caps) used to support prosthetic devices, not to diagnose a condition.
No
The device description clearly outlines physical components such as endosseous dental implants, sealing caps, gum shapers, dental implant abutments, and fixation screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical and restorative application within the human body (maxillary and mandibular arches) to support prosthetic devices. This is a direct medical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device components are physical implants, abutments, screws, caps, and shapers designed to be surgically placed and used within the patient's mouth. They are not reagents, instruments, or software used to analyze biological samples for diagnostic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies listed are mechanical testing and biocompatibility testing, which are relevant for implantable medical devices, not IVDs.
In summary, the Zuga Dental Implant System is a medical device intended for surgical implantation and prosthetic support, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
The Zuga-Dental-Implant-System-is-indicated-for-immediate-or-delayed-implant-placement-forsurgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading
Product codes
DZE, NHA
Device Description
The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, gum shapers, dental implant abutments and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one- or two-stage procedures.
Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is aluminum oxide (Al2O3) blasted then passivated. These are offered in diameters from 3.5 to 5.5mm in diameter with lengths ranging from 8mm to 17mm. Sizematched anterior and posterior abutments are offered having post heights from 4.0 to 7.0mm. These are fastened to the implant using a fixation screw. Sealing caps and gum shapers provide protection to the abutment connection threads during endosseous and gingival healing.
The implants are provided sterile, the remaining components must be sterilized prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular 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)
Pre-clinical testing of the Zuga™ Dental Implant System included:
- . Mechanical testing per ISO 14801
- Cytotoxicity testing per ISO 10993-5 .
- . Surface analysis by FTIR & SEM-EDS
No clinical data was used in support of this submission.
The Zuga™ Dental Implant System devices possess the same intended use and technological characteristics as the predicate devices. This with the information provided in the submission permit the conclusion that the Zuga™ Dental Implant System is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043428, K061323, K100724, K083544, K101201, K070841, K071161
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
K1226664
510(k) Summary
Date: Sponsor: 30 August 2012
APR 3 0 2013
Contact Person: Trade Names: Device Classification
Classification Names:
Regulation:
Device Product Codes: Device Description:
Indications for Use:
Materials:
Predicate Devices:
Zuga Medical Inc. 1163 East 40th Street, Suite 202 Cleveland, OH 44114 Phone: 216.292.5910 Facsimile: 216.292.5911
Chan Wang, CEO
Zuga™ Dental Implant System
Class II
Implant, endosseous, root-form & Abutment, implant, dental. endosseous
872.3640
DZE & NHA
The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, gum shapers, dental implant abutments and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one- or two-stage procedures.
Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is aluminum oxide (Al2O3) blasted then passivated. These are offered in diameters from 3.5 to 5.5mm in diameter with lengths ranging from 8mm to 17mm. Sizematched anterior and posterior abutments are offered having post heights from 4.0 to 7.0mm. These are fastened to the implant using a fixation screw. Sealing caps and gum shapers provide protection to the abutment connection threads during endosseous and gingival healing.
The implants are provided sterile, the remaining components must be sterilized prior to use.
The Zuga Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Zuga™ Dental Implant System components including implant, abutments, sealing caps and gum shapers are manufactured from titanium (Grade 4) as described by ASTM F67. The Zuga™ Dental Implant System fixation screw is manufactured from titanium alloy (Ti-6Al-4V) as described by ASTM F136.
Reliadent Dental Implant System (K043428 and K061323) Biomet 3i Certain® System (K100724) KAT System (K083544 and K101201) Southern Implants (K070841, K071161)
1
Technological Characteristics: The fundamental scientific technology of the Zuga™ system is the same as previously cleared devices as shown below, i.e., each of the Zuga design features is common to one or more of the predicates.
| System: | Zuga | Reliadent | Biomet 3i | KAT | Southern
Implants |
|-----------------------------|---------------------------------------|---------------------------------------------|---------------------------------------|--------------------------------------------------------------------------|---------------------------------------|
| Material of
manufacture: | Titanium | Titanium | Titanium,
Titanium alloy | Titanium alloy | Titanium |
| Design: | | | | | |
| Endosseous implant | Root-form,
Straight | Root-form,
Straight | Root-form,
Straight and
tapered | Root-form,
Straight and
tapered | Root-form,
Straight and
tapered |
| Method of
stabilization | Threaded
fixation | Threaded
fixation | Threaded
fixation | Threaded
fixation | Threaded fixation |
| Range of Diameters | 3.5 – 5.5mm | 3.0 – 5.5mm | 3.25 – 6mm | 2.5 – 8mm | – |
| Range of Lengths | 8 – 17mm | 8 – 16mm | 8.5 – 20mm | 6 – 14mm | – |
| Surface treatment | Yes, Al2O3
blasted,
passivated | Yes, Titanium
blasted and
acid etched | Yes, acid
etched | Yes, Al2O3
blasted,
passivated | Yes, Al2O3
blasted |
| Color-coding | Seating surface | Anodized
seating | Seating surface | None | None |
| Sterilization | Sterile, gamma
radiation | Sterile, gamma
radiation | Sterile, gamma
radiation | Sterile, gamma
radiation | Sterile, gamma
radiation |
| Abutments | Standard | Standard,
angled | – | Standard,
angled | Standard, angled |
| Sterilization | Non-sterile | Non-sterile | – | Non-sterile | – |
| Connection to
implant | Hex alignment,
screw
attachment | Hex alignment,
screw
attachment | – | Indexing key
alignment, 1.5°
locking taper,
screw
attachment | – |
| Color-coding | Connection
interface | Connection
interface | – | – | – |
Performance Data:
Pre-clinical testing of the Zuga™ Dental Implant System included:
- . Mechanical testing per ISO 14801
- Cytotoxicity testing per ISO 10993-5 .
- . Surface analysis by FTIR & SEM-EDS
No clinical data was used in support of this submission.
Conclusion:
The Zuga™ Dental Implant System devices possess the same intended use and technological characteristics as the predicate devices. This with the information provided in the submission permit the conclusion that the Zuga™ Dental Implant System is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 30, 2013
Zuga Medical, Incorporated C/O Karen E. Warden, PhD President ---BackRoads Consulting, Incorporated P.O. Box 566 CHESTERLAND OH 44026-2141
Re: K122664
Trade/Device Name: Zuga™ Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 16, 2013 Received: April 18, 2013
Dear Dr. Warden:
We have reviewed vour Section 510(k) premarket notification of intent to market the device i 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.
3
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 devicerelated 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/3/Picture/7 description: The image contains the text "Kwame O. Ulmer-S". The text is arranged in two lines, with "Kwame O." on the top line and "Ulmer-S" on the bottom line. There is a design in the background that is made up of geometric shapes.
for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number: K122664
Device Name: Zuga™ Dental Implant System
Indications for Use:
The Zuga-Dental-Implant-System-is-indicated-for-immediate-or-delayed-implant-placement-forsurgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading
Prescription Use _______________ OR Over-the-Counter Use_
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Mary S. Runner-5
DN: c=US, o=U.S. Government,
ou=HHS, ou=FDA, ou=People,
Susan Runner, DDSMAcn=Mary S. Runner-5.
0.9.2342.19200300.100.1.1=1300087
950
Date: 2013.04.29 15:57:18-04'00
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices |
510(k) Number: K122664