(313 days)
No
The summary describes a physical dental abutment made of titanium and its mechanical testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a "patient-specific prosthetic component" and an "implant abutment" intended to "provide support for a prosthetic restoration," indicating it is a structural component of a dental prosthesis, not a device that directly treats or prevents disease or affects the body's structure/function therapeutically.
No
The DGA Abutment is a prosthetic component for dental implants, providing support for tooth prostheses. Its function is mechanical support, not the detection, diagnosis, or monitoring of diseases or conditions.
No
The device description explicitly states it is an endosseous implant abutment made of titanium and includes physical components (abutment and screws).
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 DGA Abutment is a "patient-specific prosthetic component directly connected to the endosseous dental implant" and is used "as a support for single or multiple tooth prostheses". This describes a device used in vivo (within the body) for structural support and restoration.
- Device Description: The description details a physical component made of titanium that is placed into a dental implant. This is consistent with a medical device used for implantation and support, not for testing samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment. The device itself is the treatment/restoration component.
IVD devices are used to perform tests outside of the body on samples taken from the body. The DGA Abutment is a device that is placed inside the body.
N/A
Intended Use / Indications for Use
DGA Abutment is a patient-specific prosthetic component directly connected to the endosseous dental implant (details as below) and is intended for use as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Product codes
NHA
Device Description
DGA Abutment is endosseous implant abutment which is placed into a corresponding dental implant to provide support for a prosthetic restoration. DGA Abutment is made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F136). The DGA Abutment is mounted on the implant with a screw. Each abutment is supplied with two identical screws which are used for:
- a. For fixing into the endosseous implant.
- b. For dental laboratory use during fabrication of restoration.
The screw is also made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible
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)
The fatigue testing of the DGA Abutment was conducted in accordance with ISO 14801: 2016 Dentistry -- Implants -- Dynamic loading test for endosseous dental implants and FDA guidance " Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments", the finished assembled implant,abutment and screw systems were used to tested.
Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible OEM implant body, OEM abutment, and OEM fixation screw. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.Static and fatigue testing according to ISO 14801 were performed on worst case scenario. The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate.
Biocompatibility testing were conducted as per ISO 10993 series of standards, such as cytotoxicity, sensitization and irritation, these tests suggest that DGA Abutment has no cytotoxicity, no sensitization and no irritation and is safety for patient.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 5, 2024
Modern Dental Laboratory (DG) Co., Ltd. Robin Liu Compliance Manager Room 102 & 1102 & Floor 4-10, Block 1 Modern Dental Industrial Park NO. 7 Nantou, Songshan Lake Hi-Tech Industrial Zone Dongguan, Guangdong 523000 CHINA
Re: K231210
Trade/Device Name: DGA Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 5, 2024 Received: February 5, 2024
Dear Robin Liu:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
2
3
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K231210
Device Name
DGA Abutment
Indications for Use (Describe)
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
5. 510(k) Summary
5.1 Submitter Information
| Company Name: | Modern Dental Laboratory (DG) Co.,Ltd. |
|---|---|
| Company Address: | Room 102&1102&Floor 4-10,Block 1 Modern Dental |
| Industrial Park, No.7 Nantou, Songshan Lake Hi-Tech | |
| Industrial Zone 523000 Dongguan,Guangdong People's | |
| Republic of China | |
| Company Phone: | 0769-22899211 |
| Contact Person: | Robin Liu |
| Email: | Robin.liu@moderndentallab.com |
| Date Prepared | March 5,2024 |
5.2 Device Identification
| Device Model Name: | DGA Abutment |
|---|---|
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 872.3630 |
| Product Code: | NHA |
| Class | II |
| Panel | Dental |
5.3 Predicated Devices
| Primary Predicate Device: | K213961 |
|---|---|
| Reference Device: | K151295, K142813 |
5.4 Device Description
DGA Abutment is endosseous implant abutment which is placed into a corresponding dental implant to provide support for a prosthetic restoration. DGA Abutment is made of titanium grade Ti-6Al-4V ELI (meets ASTM Standard F136). The DGA Abutment is mounted on the implant with a screw. Each abutment is supplied with two identical screws which are used for:
- a. For fixing into the endosseous implant.
- b. For dental laboratory use during fabrication of restoration.
The screw is also made of titanium grade Ti-6AI-4V ELI (meets ASTM Standard F136).
| Brand | System | Platform | Implant body diameter | 510(k) number |
|---|---|---|---|---|
| Tissue Level | ||||
| (ST) | RN | 4.1mm,4.8mm | K122855 | |
| Straumann | WN | 4.8mm | K122855 |
DGA Abutment is compatible with the following implant
5
| Abutment post
height (length
above collar/
gingival height) | Angulation | Abutment
diameter | Wall thickness | Gingival height |
|----------------------------------------------------------------------|---------------|----------------------|---------------------|-------------------|
| 4-9 mm
(±0.2mm) | 0°
(±0.1°) | 4-7 mm
(±0.03mm) | ≥0.4mm
(±0.05mm) | 0-7mm
(±0.2mm) |
The range of design parameters of DGA Abutment please refer to the following sheet.
5.5 Indication for Use
DGA Abutment is a patient-specific prosthetic component directly connected to the endosseous dental implant (details as below) and is intended for use as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| Brand | System | Platform | Implant body diameter | 510(k) number |
|---|---|---|---|---|
| Straumann | Tissue Level (ST) | RN | 4.1mm,4.8mm | K122855 |
| WN | 4.8mm | K122855 |
5.6 Technological Characteristics
-
. Performance Specification
The DGA Abutment is designed to serve as a connection component between a dental implant and a dental prosthesis and to remain for indefinitely in the oral cavity. As such it must fulfil the following - -
a. Made with a biocompatible material suitable for permanent mucosal contact.
-
Provide an aesthetic profile from the implant up to the dental prosthesis. b.
-
Provide sufficient strength to withstand masticatory forces. C.
-
. Mechanical Properties
The fatigue testing of the DGA Abutment was conducted in accordance with ISO 14801: 2016 Dentistry -- Implants -- Dynamic loading test for endosseous dental implants and FDA guidance " Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments", the finished assembled implant,abutment and screw systems were used to tested.
. Material Properties
The DGA Abutment is made of titanium grade Ti-6AI-4V which meets ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications.To further confirm finished DGA Abutment's safety, some biocompatibility testing were conducted as per ISO 10993 series of standards, such as cytotoxicity, sensitization and irritation, these tests suggest that DGA Abutment has no cytotoxicity, no sensitization and no irritation and is safety for patient.
6
. Manufacturing Process
The DGA Abutment should be machined with computer numerical control equipment and tungsten carbide cutting tools ,and water soluble coolants should be employed during the machining process. Finished DGA Abutments should be thoroughly rinsed with clean water to remove the coolants.
DGA Abutment is delivered non-sterile for single use and must be cleaned and sterilized prio to use.The sterilization was carried out according to ISO 17665-1:2006. The recommended sterilization method is provided as below:
| Method | Moist heat sterilization |
|---|---|
| Cycle | Pre-vacuum |
| Temperature | 132°C (270° F) |
| Exposure time | 4 min |
| Drying Time | 20 min |
● Mode of Action
The mechanism of action is exactly same with the primary predicate device and reference device, and supports a determination of substantial equivalence.The infrastructure of the DGA Abutment is connected with the implant using screw-retained, and the superstructure of the DGA Abutment is connected with the dental prosthesis by cemented.The DGA Abutment is surgically placed in the maxillary and mandibular arches for supporting the dental restorations to restore patient's chewing function.
. MR Compatibility
Non-clinical worst-case MRI review was performed to evaluate the metallic devices in the MRI environment using scientific rationale and published literature (i.e., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system to include all variations (all compatible implant bodies, dental abutments, and fixation screws) and material compositions. The rationale addressed parameters per the FDA Guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment", including magnetically induced displacement force and torque.
Reverse Engineering Analysis ●
Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible OEM implant body, OEM abutment, and OEM fixation screw. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate
7
devices.Static and fatigue testing according to ISO 14801 were performed on worst case scenario. The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the primary predicate.
5.7 Risk Management
The risks to health have been identified, identified risks generally associated with the use of the DGA Abutment. The identifying approach of risk is specified as per the standard ISO 14971: 2019 Medical devices - Application of risk management to medical deices and ISO TR 24971: 2020 Medical devices - Guidance on the application of ISO 14971.
8
5.8 Substantial Equivalence Comparison
| Elements | Subject Device | Primary Predicate Device | Reference Device | Reference Device | Explanation |
|---|---|---|---|---|---|
| Name | DGA Abutment | TruAbutment DS | Biodenta Customised | ||
| Abutment -Titanium | Duplex Abutment | ||||
| 510(k) | |||||
| Number | New device | K213961 | K151295 | K142813 | |
| Manufactur | |||||
| er | Modern Dental | ||||
| Laboratory (DG) Co., | |||||
| Ltd. | TruAbutment Inc. | Biodenta Swiss AG | Biogenesis Co., Ltd. | ||
| Regulation | |||||
| Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same |
| Classificati | |||||
| on Name | Endosseous Dental | ||||
| Implant Abutment | Endosseous Dental Implant | ||||
| Abutment | Endosseous Dental | ||||
| Implant Abutment | Endosseous Dental Implant | ||||
| Abutment | Same | ||||
| Product | |||||
| Code | NHA | NHA | NHA | NHA | Same |
| Device | |||||
| Class | Class II | Class II | Class II | Class II | Same |
| Indication | |||||
| for Use | DGA Abutment is a | ||||
| patient-specific | |||||
| prosthetic component | |||||
| directly connected to | |||||
| the endosseous dental | |||||
| implant (details as | |||||
| below) and is intended | |||||
| for use as a support for | TruAbutment DS is a | ||||
| patient-specific CAD/CAM | |||||
| abutment, directly connected to | |||||
| endosseous dental implants and | |||||
| is intended for use as an aid in | |||||
| prosthetic rehabilitation. It is | |||||
| compatible with the following | The Biodenta | ||||
| Customized Abutment- | |||||
| Titanium is intended for | |||||
| use with dental | |||||
| implants as a support | |||||
| for single or multiple | |||||
| tooth prostheses in the | The Biogenesis Implant | ||||
| System - Kisses is indicated | |||||
| for use in partially or fully | |||||
| edentulous mandibles and | |||||
| maxillae, in support of single | |||||
| or multiple -unit restorations | |||||
| including; cemented retained, | Same. Slightly | ||||
| difference in | |||||
| description, however | |||||
| the content is | |||||
| substantial | |||||
| equivalence. | |||||
| single or multiple tooth | |||||
| prostheses in the | |||||
| maxilla or mandible of a | |||||
| partially or fully | |||||
| edentulous patient. | |||||
| Brand: Straumann | |||||
| System: Tissue Level | |||||
| (ST) | |||||
| Platform & Implant body | |||||
| diameter: RN (4.1mm, | |||||
| 4.8mm), WN (4.8mm) | |||||
| 510(k) number: | |||||
| K122855 | systems: | ||||
| • Straumann Tissue Level Implant | |||||
| (K122855, K202942): 4.1(RN), | |||||
| 4.8(RN), 6.5(WN) mm | maxilla or mandible of a | ||||
| partially or fully | |||||
| edentulous patient. | screw retained,or | ||||
| overdenture restorations, and | |||||
| terminal or intermediate | |||||
| abutment support for fixed | |||||
| bridgework. The Biogenesis | |||||
| Implant System - Kisses is for | |||||
| single and two stage surgical | |||||
| procedures.It is for delayed | |||||
| loading | The material of subject | ||||
| device is same as that | |||||
| of predicate device | |||||
| and reference device | |||||
| K151295. | |||||
| Abutment | |||||
| and Screw | |||||
| material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Ti Gr.4 | |
| Abutment | |||||
| fixation | Screw-retained | Screw-retained | Screw-retained | Screw-retained | Same |
| Abutment | |||||
| Angulation | 0° | ||||
| (±0.1°) | Max 25° | Max 30° | straight | the subject's allowed | |
| angulation is smaller | |||||
| than that of predicate | |||||
| /reference( K151295) | |||||
| device, and is same as | |||||
| that of reference | |||||
| device K142813. | |||||
| Abutment | |||||
| Diameter | 4-7 mm | ||||
| (±0.03mm) | 5.2-8.0 mm | 4.5-15 mm | 4.0-6.5mm | Belong to patient - | |
| specific slightly | |||||
| difference in | |||||
| parameter in diameter, | |||||
| however it doesn't | |||||
| affect the substantial | |||||
| equivalence. | |||||
| Abutment | |||||
| Post Height | |||||
| (length above collar/ | |||||
| gingival height) | 4-9 mm | ||||
| (±0.2mm) | 4.0-7.0 mm | 5.0 - 12.3 mm | 4.0-7.0mm | Belong to patient | |
| -specific,slightly | |||||
| difference in | |||||
| parameter in height, | |||||
| however it doesn't | |||||
| affect the substantial | |||||
| equivalence. | |||||
| Wall | |||||
| thickness | Min 0.4mm | ||||
| (±0.05mm) | Min 0.4mm | Unknown | unknown | Same as predicate | |
| device | |||||
| Belong to patient | |||||
| -specific,slightly | |||||
| Gingival | |||||
| height | 0-7mm | ||||
| (±0.2mm) | Unknown | Unknown | 1.0-7.0mm | difference in | |
| parameter in height, | |||||
| however it doesn't | |||||
| affect the substantial | |||||
| equivalence. | |||||
| Installation | |||||
| procedure | 1. The final DGA | ||||
| Abutment is attached to | |||||
| the implant using the | |||||
| corresponding dental | |||||
| screw. |
- The dental screw is | a. After osseointegration has
been successfully achieved for
the fixture, design an appropriate
CAD/CAM custom abutment
suitable to the oral environment.
b. Reproduce the configuration | An abutment screw
provided by Biodenta is
used to secure the
abutment to the
implant, whereas the
prosthesis is custom | It's not available from public
database. | Subject device is
substantial
equivalence to primary
predicate and
reference device
(K151295) . Slightly |
| | tightened in the | of the oral cavity of the patient | made and | | difference in |
| | recommended torque | through impression and send the | cement-retained on the | | description, however |
| | 3. In order to obtain the | impression to a dental laboratory | abutment. The | | the content is |
| | recommended torque, a | to fabricate the final prosthesis. | abutment screw should | | substantial |
| | dental torque wrench | Once the final prosthesis | be tightened with a | | equivalence. |
| | with a suitable screw | fabrication is completed, deliver it | manual torque wrench | | |
| | driver must be used in | to the patient to improve their | according to the | | |
| | accordance with the | masticating and aesthetic | implant manufacturer's | | |
| | relevant manufacturer's | functions. | specifications. | | |
| | instructions | When affixing an abutment | | | |
| | 4. The screw channel | onto a fixture, the recommended | | | |
| | must always be sealed | torque value is equivalent to the | | | |
| | after the abutment is | manufacturers' value for the | | | |
| | attached to the implant. | respective implant system. The | | | |
| | | torque value should be | | | |
| | | determined based on the clinical | | | |
| | | assessment of the bone quality, | | | |
| | | fixture dimensions, and | | | |
| | | prosthesis type, etc. | | | |
| CAD/CAM
Processing | Milled at Modern
Dental Laboratory
under QSR control. | All digitally designed abutments
and/or coping for use with the
TruAbutment DS abutments are
intended to be sent to a
TruAbutment-validated milling
center for manufacture. | Milled in Biodenta
milling center under
QSR control. | It's not available from public
database. | Subject device is
substantial
equivalence to primary
predicate and
reference device
(K151295) |
| Compatible
Implant | Straumann Tissue | Straumann Tissue Level Implant | Dentsply, AstraTech
OsseoSpeed | Biogenesis Implant System -
Kisses | Subject device and
primary predicate |
| System | Level Implant | (K122855, K202942): 4.1(RN), | Biomet 3i, Certain | device both are | |
| | (K122855): 4.1(RN), | 4.8(RN), 6.5(WN) mm | Internal | compatible with | |
| | 4.8(RN) ,4.8(WN) mm | | Zimmer, Screw Vent | Straumann Tissue | |
| | | | Nobel Biocare,Nobel
Replace
Nobel Biocare,Nobel
Active
Straumann, Bone Level
BioHorizons,Internal
Osstem, GS/TS
Biodenta, Bone Level
and Tapered | Level Implant | |
| Sterilizatio
n | Non-sterile | Non-sterile | Non-Sterile | Same | |
| | | | Non-Sterile | | |
Page 5 of 10
9
Page 6 of 10
10
Page 7 of 10
11
Page 8 of 10
12
13
5.9 Substantial Equivalence Conclusion
The DGA Abutment is substantially equivalent to the primary predicate device and the reference devices in terms of indication for use, technical characteristics and function. Although there are slightly differences in size parameter of devices, these differences are very minor not affecting substantial equivalence.
Therefore, the subject device, the predicate device and the reference devices are substantial equivalence.