(261 days)
No
The description focuses on the material composition, manufacturing process, dimensions, and mechanical properties of a dental implant system. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a dental implant system used to support restorations in edentulous mandibles and maxillae, which is a restorative rather than a therapeutic function.
No.
The device is a dental implant system used for supporting dental restorations and is not designed to diagnose disease or conditions.
No
The device description clearly details a physical dental implant system made of Titanium with various coatings and dimensions, including fixtures, abutments, and screws. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a dental implant system used to support dental restorations in the mandibles and maxillae. This is a surgical implant device, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details the physical components of the implant system (fixtures, abutments, screws), the materials used (Titanium, CaP, HA coating), and the surgical procedures involved (one and two stage). This aligns with a medical device intended for implantation, not a diagnostic reagent or instrument.
- Performance Studies: The performance studies described are non-clinical tests evaluating the mechanical properties (shear bonding strength, tensile bonding strength) and biological integration (HA Coating Implant Graft Test in pig bone) of the implant. These are typical tests for implantable medical devices, not IVDs which would involve analytical and clinical performance studies related to diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This dental implant system does not fit that description.
N/A
Intended Use / Indications for Use
The Dentis 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 dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
This product is the operating, dental material as placed dental implant to inner part of maxillary to sustain, maintain prosthetic repair tooth or denture, mainbody (structure of subpart) is made by Titanium (Grade 4), is treated as blasting powder, and RBM at room temperature of CaP type to reduce Bone loss to bottom 1mm of the Machine Collar. Also, screw part of below 1 mm is treated as SHS (Super High Speed) RBM HA (Hydroxyapatite) Coating at room temperature. It is connected to structure of upper part as the type of the internal.
HA Thin film coating achieved through the process in which the HA particles impact on the surface of implant with high speed.
By passing carrier gas, which comes from nitrogen tank, through the hopper containing HA particles, the HA particle and carrier gas can flow to the vacuum chamber. The vacuum chamber maintaining low pressure thanks to the vacuum pump, enable to spray the HA particles with carrier gas out in high speed(more than 500m/sec) through spray nozzle. As HA particles impact on the surface of implant, it reduced to fragment and those fragment make up thin film coating layer.
The implant diameters are 3.7, 4.1, 4.3, 4.8, 5.5, 6.0, 6.5, and 7.0 mm and the implant lengths are 7, 8, 9, 10, 12, 14, and 16mm in this system.
The system consists of 2 fixture systems, i-clean fixture and s-clean fixture, and 2 abutment systems i-clean and s-clean abutment.
The i-clean abutment system is composed of healing cap, various abutments (solid, excellent solid, octa, synocta, inocta, temporary, healing, o-ring and free), screws (cover screw, closing screw, abutment screw, cvlinder screw), gold UCLA, gold cylinder ..
The s-clean abutment system is composed of healing cap, various abutments (sole, couple, hex, temporary, o-ring, free, octa, zero margin, freemill, and MOA), and gold cylinder, and various screws (abutment, cylinder).
i-Clean Fixture is Non-submerged type, once surgery and safe structure as having 8° from center of connection part.
s-Clean Fixture is Submerged type, twice surgery and safe structure as having 11° from center of connection part.
The abutment lengths are 7, 8, 9, 10, 11, 12mm, and cuff lengths 0.5, 1, 1.5, 2, 2.5, 3, 3.5. 4. 4.5. 5.5. 7mm.
The i-Clean fixture is available with either tapered, straight, or SAVE body designs. The i-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.7mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The i-Clean straight fixture is available in diameters of 4.05, 4.25, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The i-Clean SAVE fixture is available in diameters of 5.5, 6.0, 6.5, and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The i-Clean Tapered II design contains a thread design with differs from the i-Clean Tapered fixture design. The i-Clean Tapered II has no 'micro thread' design.
The s-Clean fixture is available with either tapered, straight, or SAVE body designs. The s-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.8mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The s-Clean straight fixture is available in diameters of 4.1, 4.3, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The s-Clean SAVE fixture is available in diameters of 5.5. 6.0. 6.5. and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The s-Clean Tapered II design contains a thread design with differs from the s-Clean Tapered fixture design. The s-Clean Tapered II has no 'micro thread' design.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandibles and maxillae
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)
Non-clinical Testing data
- Measurement of the gap between fixture and abutment, rotational angle tests were successfully performed.
- Shear bonding strength test was successfully performed in accordance with ASTM F . 1147, 1044 as the result about 37 MPa over standard 34.5 MPa.
- Tensile bonding strength test was successfully performed in accordance with ASTM F -1147, 1044 as the result about 41 MPa over standard 34.5 MPa.
- -HA Coating Implant Graft Test in the pig bone for the evaluation of the stability of the coating layer was successfully performed.
- Roughness, Degree of crystallinity, Porosity, Cross section analysis, Density, Surface . area analysis, CaP ratio tests were successfully performed.
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.
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
510(K) Summary
Submitter
Dentis Co., Ltd. Jung Seob Guem #951, Woram-dong, Dalseo-Gu Daegu citv South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806
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
Device Information
Trade Name: HAPTITE Coating Implant System Common Name: Endosseous Dental Implant Classification Name: Implant, Endosseous, Root-Form Product Code: DZE Regulation Number: 872.3640 Device Class: Class II Date Prepared: 2011-5-11
General Description
This product is the operating, dental material as placed dental implant to inner part of maxillary to sustain, maintain prosthetic repair tooth or denture, mainbody (structure of subpart) is made by Titanium (Grade 4), is treated as blasting powder, and RBM at room temperature of CaP type to reduce Bone loss to bottom 1mm of the Machine Collar. Also, screw part of below 1 mm is treated as SHS (Super High Speed) RBM HA (Hydroxyapatite) Coating at room temperature. It is connected to structure of upper part as the type of the internal.
HA Thin film coating achieved through the process in which the HA particles impact on the surface of implant with high speed.
By passing carrier gas, which comes from nitrogen tank, through the hopper containing HA particles, the HA particle and carrier gas can flow to the vacuum chamber. The vacuum chamber maintaining low pressure thanks to the vacuum pump, enable to spray the HA particles with carrier gas out in high speed(more than 500m/sec) through spray nozzle. As HA particles impact on the surface of implant, it reduced to fragment and those fragment make up thin film coating layer.
The implant diameters are 3.7, 4.1, 4.3, 4.8, 5.5, 6.0, 6.5, and 7.0 mm and the implant lengths are 7, 8, 9, 10, 12, 14, and 16mm in this system.
The system consists of 2 fixture systems, i-clean fixture and s-clean fixture, and 2 abutment systems i-clean and s-clean abutment.
The i-clean abutment system is composed of healing cap, various abutments (solid, excellent solid, octa, synocta, inocta, temporary, healing, o-ring and free), screws (cover screw,
1
closing screw, abutment screw, cvlinder screw), gold UCLA, gold cylinder ..
The s-clean abutment system is composed of healing cap, various abutments (sole, couple, hex, temporary, o-ring, free, octa, zero margin, freemill, and MOA), and gold cylinder, and various screws (abutment, cylinder).
i-Clean Fixture is Non-submerged type, once surgery and safe structure as having 8° from center of connection part.
s-Clean Fixture is Submerged type, twice surgery and safe structure as having 11° from center of connection part.
The abutment lengths are 7, 8, 9, 10, 11, 12mm, and cuff lengths 0.5, 1, 1.5, 2, 2.5, 3, 3.5. 4. 4.5. 5.5. 7mm.
The i-Clean fixture is available with either tapered, straight, or SAVE body designs. The i-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.7mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The i-Clean straight fixture is available in diameters of 4.05, 4.25, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The i-Clean SAVE fixture is available in diameters of 5.5, 6.0, 6.5, and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The i-Clean Tapered II design contains a thread design with differs from the i-Clean Tapered fixture design. The i-Clean Tapered II has no 'micro thread' design.
The s-Clean fixture is available with either tapered, straight, or SAVE body designs. The s-Clean tapered fixture is available in diameters of 3.7, 4.1, 4.3, and 4.8mm and each diameter is available in lengths of 8, 10, 12, or 14mm. The s-Clean straight fixture is available in diameters of 4.1, 4.3, and 4.75mm and each diameter is available in lengths of 8, 10, 12, 14, and 16mm. The s-Clean SAVE fixture is available in diameters of 5.5. 6.0. 6.5. and 7.0mm and each diameter is available in lengths of 7, 8, 9, 10, and 12mm. The s-Clean Tapered II design contains a thread design with differs from the s-Clean Tapered fixture design. The s-Clean Tapered II has no 'micro thread' design.
Indication for Use
The Dentis 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 dedicated for one and two stage surgical procedures and not dedicated for immediate loading. This system is intended for delayed loading.
Predicate Devices & Comparison
The subject device is substantially equivalent to the following predicate device:
- DIO BIOTITE-H IMPLANT SYSTEM manufacture by DIO Deparment, DSI (K073070) .
- Replace HA coated implant manufactured by Nobel Biocare USA, INC. (K022424) .
Testing and other comparisons have established that the subject of HAPTITE implant system is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to the predicate device currently marketed in the U.S.
2
| Subject device | Predicate device | |||
|---|---|---|---|---|
| Device | ||||
| name | Dentis HAPTITE | |||
| Implant system | Dentis | |||
| Implant | ||||
| System | DIO BIOTITE-H | |||
| IMPLANT SYSTEM | Replace HA Coated | |||
| Implant | ||||
| 510(k) | ||||
| number | N/A | K082843/ | ||
| K073486 | K073070 | K022424 | ||
| Manufac | ||||
| turer | Dentis Co., Ltd. | Dentis | ||
| Co., Ltd. | DIO Department, DSI, | |||
| Inc. | Nobel Biocare USA, Inc. | |||
| Intended | ||||
| use | ldentical to | |||
| predicate devices | ldentical | |||
| to | ||||
| predicate | ||||
| devices | The implants are | |||
| indicated for surgical | ||||
| placement in the | ||||
| upper or lower jaw to | ||||
| provide a means for | ||||
| prosthetic attachment | ||||
| in single tooth | ||||
| restoration and in | ||||
| partially or fully | ||||
| edentulous spans with | ||||
| multiple single teeth, | ||||
| or as a terminal or | ||||
| intermediary abutment | ||||
| for fixed or removable | ||||
| bridgework, and to | ||||
| retain overdentures. | The implants are indicated | |||
| for surgical placement in | ||||
| the upper or lower jaw to | ||||
| provide a means for | ||||
| prosthetic attachment in | ||||
| single tooth restoration and | ||||
| in partially or fully | ||||
| edentulous spans with | ||||
| multiple single teeth, or as | ||||
| a terminal or intermediary | ||||
| abutment for fixed or | ||||
| removable bridgework, and | ||||
| to retain overdentures. | ||||
| Material | CP. GR.4 | |||
| ASTM F67 | CP. GR.4 | |||
| ASTM | ||||
| F67 | CP. GR.3 and GR.4 | |||
| ASTM F67 | CP. GR.3 and GR.4 | |||
| ASTM F67 | ||||
| Design | Tapered and | |||
| straight | Tapered | |||
| and | ||||
| straight | Tapered | Straight | ||
| Implant | ||||
| diameter | 3.7, 4.1, 4.3, 4.8, | |||
| 5.5, 6.0, 6.5 and | ||||
| 7.0mm | 3.5, 3.7, | |||
| 4.1, 4.3, | ||||
| 4.8, 5.1, | ||||
| 5.5, 6.0, | ||||
| 6.5 and | ||||
| 7.0mm | 3.8, 4.1, 4.5, 4.8, and | |||
| 5.3mm | 3.5, 4.3, 5.0, 6.0mm | |||
| Implant | ||||
| length | 7, 8, 9, 10, 12, 14 | |||
| and 16mm | 7, 8, 10, | |||
| 12 and | ||||
| 14mm | 8-14mm | 10,13,16mm | ||
| Attachm | ||||
| ents | Various abutments | |||
| and components | Various | |||
| abutment | ||||
| s and | ||||
| compone | ||||
| nts | Various abutments | |||
| and components | Various abutments and | |||
| components | ||||
| Surface | ||||
| treatment | HA coating | RBM | HA coating | HA coating |
| Coating | ||||
| method | Super High Speed | |||
| Blast Coating | ||||
| Process | Non | |||
| Coating | Electrochemical1 | Plasma-sprayed HA | ||
| coating2 | ||||
| Coating | ||||
| thickness | ||||
| s | 1~2µm | 15±5µm1 | >5µm2 | |
| Solubility | insoluble | Soluble1 | Insoluble2 | |
| Surface | ||||
| chemistry | 100% crystalline | |||
| HA | 95% Brushite + 5% | |||
| hydroxyapatite1 | Amorphous + crystalline | |||
| HA2 | ||||
| Shear | ||||
| strength | $ \approx $ 37MPa | 13MPa1 | $ \approx $ 37.4MPa | |
| Morphology | Image: Morphology 1 | Image: Morphology 2 | Image: Morphology 3 | |
| Gamma | ||||
| sterilized | Yes | Yes | Yes | |
| Product | ||||
| Code | DZE | DZE | DZE |
.
:
·
.
.
י
3
Non-clinical Testing data
- Measurement of the gap between fixture and abutment, rotational angle tests were successfully performed.
- Shear bonding strength test was successfully performed in accordance with ASTM F . 1147, 1044 as the result about 37 MPa over standard 34.5 MPa.
- Tensile bonding strength test was successfully performed in accordance with ASTM F -1147, 1044 as the result about 41 MPa over standard 34.5 MPa.
- -HA Coating Implant Graft Test in the pig bone for the evaluation of the stability of the coating layer was successfully performed.
- Roughness, Degree of crystallinity, Porosity, Cross section analysis, Density, Surface . area analysis, CaP ratio tests were successfully performed.
Conclusion
The HAPTITE Coating Implant System, subject 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. HAPTITE Implant system, as designed and manufactured, is as safe and effective as the predicate devices and therefore is believed to be substantially equivalent to Predicate devices.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the left side of the logo. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dentis Company, Limited Ms. April Lee Consultant Kodent Incorporated 325 N. Puente Street, Unit B Brea, California 92821
FEB - 1 2012
Re: K111364
Trade/Device Name: HAPTITE Coating Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: January 30, 2012 Received: January 30, 2012
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.
5
Page 2 - Ms. Lee
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh 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
6
Indication for Use
510(K) Number (if known):
HAPTITE Coating Implant System Device Name:
The HAPTITE Coating 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 This system is dedicated for one and two stage surgical procedures and not dedicated bridgework. for immediate loading. This system is intended for delayed loading
Prescription Use X (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
Swer Rose
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: