(141 days)
Not Found
No
The document describes a physical dental implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a dental implant system used for prosthetic support, not for treating a disease or condition in a therapeutic manner.
No
The device is a dental implant system, a therapeutic device designed for prosthetic support, not for diagnosing conditions.
No
The device description clearly states it is a dental implant made of titanium metal, which is a physical hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the INNO SLA Submerged Implant System is a dental implant made of titanium intended to be surgically placed in the bone of the jaw. Its purpose is to support dental restorations.
- Lack of Mention of Biological Samples or Testing: There is no mention of the device being used to analyze biological samples or perform any kind of diagnostic test.
The device is a surgically implanted medical device used for structural support in the jaw.
N/A
Intended Use / Indications for Use
The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abulment support for fixed bridgework, this system is intended for delayed loading.
The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purposed of providing prosthetic support for dental restorations (Crown, bridge, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The INNO SLA Submerged Implant System is a dental implant made of titanium(Grade 4) metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used. the claims, the material composition employed and performance characteristics. The differences between the subject device and the predicate device are shape and surface treatment. The INNO SLA Submerged Implant System has one-stage and two-stage surgery. The surface treatment method of the subject device is S.L.A(Sand-blasted Large grit Acid-etched).
The fixture diameters are 3.7. 4.2, 4.6, 5.1, and 6.0mm and the implant lengths are 7.0, 7.5, 8, 9.5. 10. 11.5. 12. and 14mm in this system. The available lengths for each diameter of the fixtures are the following:
- 03.7mm with lengths of 8mm, 10mm, 12mm, and 14mm
- 04.2mm with lengths of 8mm, 10mm, 12mm, and 14mm .
- 04.6mm with lengths of 8mm, 10mm, 12mm, and 14mm ●
-
- 1mm with lengths of 7mm, 8mm, 12mm, 12mm, and 14mm .
- 06.0mm with lengths of 7mm, 7.5mm, 9.5mm, and 11.5mm .
The abutments are made of titanium alloy and plastic and it is intended for use to made temporary prosthesis. It consists of Abutment and Coping Screw. The Abutment diameters are 3.7 ~ 6.5mm, and lengths 7.9 ~ 17.7mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae, maxillary or mandibular molar areas
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)
No additional testing was performed for the subject 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
§ 872.3640 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
K132247
510(k) Submission - INNO SLA Submerged Implant System
Cowellmedi Co., Ltd.
510(K) Summary
Submitter
Cowellmedi Co., Ltd. Kyu Su Kim 155-4, Gamjeon-dong, Sasang-gu, Busan, 617-801 Republic of Korea Phone: +82-51-314-2028 Fax: +82-51-316-2628
Official Correspondent Kodent Inc. April Lee 325 N. Puente st. Unit B Brea, CA 92821 Email: kodentinc@gmail.com Phone: 714-525-0114 Fax: 714-525-01116
Date prepared: 7/15/2013
Indications for Use
The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abulment support for fixed bridgework, this system is intended for delayed loading.
The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purposed of providing prosthetic support for dental restorations (Crown, bridge, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
General Description
The INNO SLA Submerged Implant System is a dental implant made of titanium(Grade 4) metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used. the claims, the material composition employed and performance characteristics. The differences between the subject device and the predicate device are shape and surface treatment. The INNO SLA Submerged Implant System has one-stage and two-stage surgery. The surface treatment method of the subject device is S.L.A(Sand-blasted Large grit Acid-etched).
The fixture diameters are 3.7. 4.2, 4.6, 5.1, and 6.0mm and the implant lengths are 7.0, 7.5, 8, 9.5. 10. 11.5. 12. and 14mm in this system. The available lengths for each diameter of the fixtures are the following:
- 03.7mm with lengths of 8mm, 10mm, 12mm, and 14mm
- 04.2mm with lengths of 8mm, 10mm, 12mm, and 14mm .
- 04.6mm with lengths of 8mm, 10mm, 12mm, and 14mm ●
-
- 1mm with lengths of 7mm, 8mm, 12mm, 12mm, and 14mm .
- 06.0mm with lengths of 7mm, 7.5mm, 9.5mm, and 11.5mm .
The abutments are made of titanium alloy and plastic and it is intended for use to made temporary prosthesis. It consists of Abutment and Coping Screw. The Abutment diameters are 3.7 ~ 6.5mm, and
DEC 6 2013
1
lengths 7.9 ~ 17.7mm.
Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate device:
- Cowell Implant System by Cowellmedi Co., Ltd. (K100850) .
- Implantium II by Dentium Co., Ltd. (K060501) .
| Subject device | Predicate device | Predicate Device | |
|---|---|---|---|
| Device name | INNO SLA | ||
| Submerged Implant | |||
| System | Cowell Implant System | Implantium II | |
| 510(k) number | N/A | K100850 | K060501 |
| Manufacturer | Cowellmedi Co., | ||
| Ltd. | Cowellmedi Co., Ltd | Dentium Co., Ltd. | |
| Intended use | Identical to | ||
| predicate | The INNO SLA Submerged | ||
| Implant System is indicated | |||
| for use in partially or fully | |||
| edentulous mandibles and | |||
| maxillae, in support of single | |||
| or multiple-unit restorations | |||
| including: cemented retained, | |||
| screw retained, or | |||
| overdenture restorations, and | |||
| terminal or intermediate | |||
| abutment support for fixed | |||
| bridgework, this is intended | |||
| for delayed loading. | |||
| The implants with diameters | |||
| larger than 5.0mm are | |||
| intended to be surgically | |||
| placed in the maxillary or | |||
| mandibular molar areas for | |||
| the purposed of providing | |||
| prosthetic support for dental | |||
| restorations (Crown, bridge, | |||
| and overdentures) in partially | |||
| or fully edentulous | |||
| individuals. These implants | |||
| are intended to be used where | |||
| smaller implants have failed. | Implantium II is | ||
| intended to be | |||
| surgically placed in the | |||
| bone of the upper or | |||
| lower jaw arches to | |||
| provide support for | |||
| prosthetics devices, | |||
| such as artificial teeth. | |||
| and to restore the | |||
| patient's chewing | |||
| function. | |||
| Material | CP Titanium, Gr.4 | ||
| ASTM F67 | CP Titanium, Gr.4 | ||
| ASTM F67 | CP Titanium, Gr.4 | ||
| ASTM F67 | |||
| Design | Submerged | Submerged | Submerged |
| Fixture Design | Image: INNO SLA Submerged Implant System Fixture Design | Image: Cowell Implant System Fixture Design | Image: Implantium II Fixture Design |
| Implant diameter | 3.7, 4.2, 4.6, 5.1, 6.0mm | 3.6, 3.7, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5mm | 3.6 - 7.0 mm |
| Implant length | 7, 7.5, 8, 9.5, 10, 11.5, 12, 14mm | 8, 9, 10, 11, 12, 14, 16, 18mm | 7 - 14 mm |
| Components | Various abutments | ||
| and components | Various abutments and | ||
| components | Various abutments and | ||
| components | |||
| Surface treatment | SLA | RBM | SLA |
| Gamma sterilized | Yes | Yes | Yes |
| Product Code | DZE | DZE | DZE |
2
Comparison Analysis
The INNO SLA Submerged Implant System has a substantially equivalent intended use as the identified predicate. The INNO SLA Submerged Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed. manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments, and they are all constructed of titanium.
INNO SLA Submerged Implant System is substantially equivalent in materials, indications and intended use, packaging, labeling, and performance to the predicate device currently marketed in the U.S.
Only the difference between the subject device and the predicate is the surface treatment method and the Fixture's external design.
Any differences in technology characteristics are accompanied by information that demonstrated the device is safe and effective as the predicate and do not raise different questions of safety and effectiveness than the predicate
Non-Clinical Data
No additional testing was performed for the subject device.
Conclusion
The INNO SLA Submerged Implant System, subject device of this submission, constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. The risks of using the device as recommended pose no greater risks than other implant systems. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, INNO SLA Submerged Implant System and its predicate devices are substantially equivalent.
3
Image /page/3/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002
December 6, 2013
Cowellmedi Company, Limited C/O Ms. April Lee Consultant Kodent, Incorporated 325 North Puente Street, Unit B Brea, CA 92821
Re: K132242
Trade/Device Name: INNO SLA Submerged Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: October 30, 2013 Received: November 1, 2013
Dear Ms. Lee:
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
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kwame O. Ulmer -S
for
Erin I. Keith, 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
Indication for Use
510(K) Number (if known): K132242
Device Name: INNO SLA Submerged Implant System
The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework, this system is intended for delayed loading.
The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purposed of prosthetic support for dental restorations (Crown, bridge, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Mary S. Runner -
S
Susan Run DDS, MA 2013.12.05
09:41:26-05'00'