(246 days)
No
The summary describes a CAD/CAM abutment system for dental implants, focusing on design and manufacturing processes. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as a support for dental prostheses for partially or fully edentulous patients, which implies a direct medical benefit in restoring oral function and aesthetics.
No
Explanation: The device is described as an abutment intended to support single or multiple tooth prostheses, indicating it is a prosthetic component rather than a tool for diagnosis.
No
The device description explicitly states that the device includes physical components made of titanium alloy (Hybrid Link Abutment and Patient-Specific Abutment) and is intended to be manufactured at a milling center, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The DIO CAD/CAM Abutment is a dental implant component used to support prostheses in the mouth. It is a physical device implanted in the patient's oral cavity.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens. The device's function is mechanical support for dental restorations.
Therefore, the DIO CAD/CAM Abutment falls under the category of a medical device, specifically a dental implant component, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The DIO CAD/CAM Abutment includes two CAD/CAM abutment designs, Hybrid Link Abutment and Patient-Specific Abutment.
-
Hybrid Link abutment
Hybrid Link abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The hybrid link abutment is composed of two-piece abutment that is a hybrid link at the bottom and a coping (CAD/CAM patient specific superstructure) at the top. The hybrid link abutments are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The diameters of Hybrid Link Abutment are 4.0/4.5/5.5mm. Hybrid Link abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Hybrid Link Abutment. -
Patient-Specific Abutment
Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific Abutment are 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 and two connection designs (Hex, Non-hex).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxilla or mandible, Oral Cavity
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 was conducted to evaluate the device's substantial equivalence.
Conducted tests:
- Fatigue Tests according to ISO 14801:2016
- End User Steam Sterilization Tests according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010
- Cytotoxicity testing according to ISO 10993-5:2009
Leveraged tests from predicate devices (K122519):
- Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993- 10:2010.
Key results: The results of the above tests have met the criteria of the standard and demonstrated the substantial equivalence with the predicate device. Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing. Clinical testing was not necessary to establish substantial equivalency of the 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.
K111421, K143505, K112730, K161987, K122519, K170608, K073173, K131117
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
§ 872.3630 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 contains 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.
December 21, 2018
DIO Corporation % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K181037
Trade/Device Name: DIO CAD/CAM Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 19, 2018 Received: November 26, 2018
Dear April 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. 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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181037
Device Name DIO CAD/CAM Abutment
Indications for Use (Describe)
Indication for Use
DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|
| UF(II) Narrow Implant System | 3.0/3.3 | 3.0/3.3 |
| UF Sub merged Implant System | 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 | 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 |
| UF(II) Implant System | 3.8/4.0/4.5/5.0/5.5 | 3.8/4.0/4.5/5.0/5.5 |
Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.
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)
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3
510(k) Summary
Submitter
DIO Corporation Jiae, Park 66, Centum Seo-ro, Haeundae-gu Busan, 48058 Republic of Korea Email: japark@dio.co.kr Phone: +82-51-745-7836
Official Correspondent
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
Device Information
- Trade Name: DIO CAD/CAM Abutment
- Common Name: Endosseous dental implant abutment
- Classification Name: Abutment, Implant, Dental, Endosseous .
- Product Code: NHA
- . Panel: Dental
- Regulation Number: 21 CFR 872.3630 ●
- . Device Class: Class II
- Date prepared: 12/21/2018 ●
Predicate Devices:
The subject device is substantially equivalent to the following predicate device:
Primary Predicate
-
Medentika CAD/CAM Abutment (K150203)
Reference Devices -
Sirona Dental CAD/CAM System (K111421)
-
Zimmer® patient Specific Abutment, Internal Hex, Titanium(K143505) ●
-
Encode Patient Specific Abutment for Straumann Bone Level Connection(K112730) ●
-
. UF(II) Narrow Implant System (K161987)
-
UF Sub Merged Implant System (K122519) ●
-
UF(II) Implant System (K170608)
-
Self-Adhesive Resin Cement (K073173)
-
. ZIRMON SERIES (K131117)
4
Device Description
The DIO CAD/CAM Abutment includes two CAD/CAM abutment designs, Hybrid Link Abutment and Patient-Specific Abutment.
1) Hybrid Link abutment
Hybrid Link Abutment
Hybrid Link abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The hybrid link abutment is composed of two-piece abutment that is a hybrid link at the bottom and a coping (CAD/CAM patient specific superstructure) at the top. The hybrid link abutments are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The diameters of Hybrid Link Abutment are 4.0/4.5/5.5mm.
Hybrid Link abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Hybrid Link Abutment.
The proposed devices are compatible with the following device.
Dental Implants
| Proprietary Name | UF(II) Narrow
Implant System | UF Sub merged Implant
System | UF(II) Implant System |
|--------------------------------------------------|---------------------------------|-------------------------------------|----------------------------------|
| Compatible Implants
(Knumber) | K161987 | K122519 | K170608 |
| Implant diameter size | 3.0/3.3 | 3.8/4.0/4.5/5.0/5.5/6.0/6.5
/7.0 | 3.8/4.0/4.5/5.0/5.5 |
| Implant Interface
Connection
Type/Size(mm) | Internal connection
type/2.3 | Internal connection
type/3.35 | Internal connection
type/3.35 |
| Type of Implant-
Abutment Connection | Hex/Non Hex | Hex/Non Hex | Hex/Non Hex |
Raw material blanks
- K131117 ZIRMON SERIES manufactured by KUWOTECH CO., LTD .
Raw material cement
- . K073173 Self-Adhesive Resin Cement manufactureed by Densply is the cement
The coping that composes the final abutment should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the Hybrid link abutment.
The coping would be manufactured by DIO Corporation only with design input using CAD/CAM Software from and by DIO Corporation milling center.
Design Limitation for Superstructure:
| Super structure design Limitation (Unit: mm) | |||
|---|---|---|---|
| Range (Diameter) | Range (Height) | Range (Wall | |
| thickness) | Range (Angle) |
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| Min .
4.0mm
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| -------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------- | --------------- |
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2) Patient-Specific Abutment
Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.
The diameters of patient-specific Abutment are 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 and two connection designs (Hex, Non-hex).
Patient-Specific Abutment is compatible with following Implant Systems.
| Proprietary Name | UF(II) Narrow Implant
System | UF Sub merged
Implant System | UF(II) Implant
System |
|--------------------------------------------------|---------------------------------|-------------------------------------|----------------------------------|
| Compatible Implants
(Knumber) | K161987 | K122519 | K170608 |
| Implant diameter size | 3.0/3.3 | 3.8/4.0/4.5/5.0/5.5/6.0
/6.5/7.0 | 3.8/4.0/4.5/5.0/5.5 |
| Implant Interface
Connection
Type/Size(mm) | Internal connection
type/2.3 | Internal connection
type/3.35 | Internal connection
type/3.35 |
| Type of Implant-
Abutment Connection | Hex/Non Hex | Hex/Non Hex | Hex/Non Hex |
Patient-specific abutments are supplied with an abutment screw previous cleared device as K122519 and K161987 and provided non-sterile.
| Model Name | Range (Diameter) | Range (Height) | Range (Angle) |
|---|---|---|---|
| CASSH | |||
| CASSN | 3.9~12.0 | 3.1~14.9 | 0~29.8° |
| CAUNH | |||
| CAUNN | 3.9~12.0 | 3.1~14.9 | 0~29.3° |
Indication for Use
DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
| Implant System Compatibility | Implant Diameter (mm) | Platform Diameter (mm) |
|---|---|---|
| UF(II) Narrow Implant System | 3.0/ 3.3 | 3.0/ 3.3 |
| UF Sub merged Implant System | 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 | 3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 |
| UF(II) Implant System | 3.8/4.0/4.5/5.0/5.5 | 3.8/4.0/4.5/5.0/5.5 |
Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.
6
Summaries of Technological Characteristics
The subject device is substantially equivalent to the currently cleared devices. They are substantially equivalent in intended use, material and connection interfaces to the implants are identical for each individual diameter and connection type. Comparison demonstrating Substantial Equivalence follows:
1) Hybrid Link Abutment
| Subject Device | Primary Predicate Device | Reference Device | |
|---|---|---|---|
| Applicant | DIO Corporation | Medentika GmbH | Sirona Dental Systems GmbH |
| Trade Name | DIO CAD/CAM Abutment | Medentika CAD/CAM Abutment | Sirona Dental CAD/CAM System |
| TiBase Abutment | |||
| 510(K) No. | K181037 | K150203 | K111421 |
| Classification Name | Endosseous Dental Implant, Abutment | ||
| (872.3630) | Endosseous Dental Implant, Abutment | ||
| (872.3630) | Endosseous Dental Implant, Abutment | ||
| (872.3630) | |||
| Product Code | NHA | NHA | NHA |
| Class | II | II | II |
| Material | Ti-6Al-4V ELI (ASTM F136) | ||
| Zirconia Oxide | Titanium Alloy | Ti-6Al-4V ELI (ASTM F136) | |
| Zirconia Oxide | |||
| Design | Titanium Base | Titanium Base | Titanium Base |
| Diameters (mm) | 4.0/4.5/5.5 | 3.25-7.0 | 3.5~6.5 |
| Superstructure | |||
| Angulation (°) | 0~15 | Up to 30 | Up to 20 |
| Superstructure | |||
| material | Zirconia | Zirconia | Zirconia |
| Sterile | Steam Sterilization by user | ||
| (Delivered non sterile) | Steam Sterilization by user | ||
| (Provided Non-Sterile) | Steam Sterilization by user | ||
| (Delivered non sterile) | |||
| Type of Retention | Screw-retained or cement retained | Cement-retained | Screw-retained or cement retained |
| Indications For Use | DIO CAD/CAM Abutment is intended for use | ||
| with dental implants as a support for single or | |||
| multiple tooth prostheses in the maxilla or | |||
| mandible of a partially or fully edentulous patient. | |||
| Medentika Preface CAD/CAM Abutments are intended for | |||
| use with dental implants as a support for single or multiple | |||
| tooth prostheses in the maxilla or mandible of a partially or | |||
| fully edentulous patient. | The Sirona Dental CAD/CAM System is | ||
| intended for use in partially or fully | |||
| edentulous mandibles and maxillae in | |||
| support of single or multiple-unit cement | |||
| retained restorations. For the titanium | |||
| bases SSO 3.5L and SBL 3.3L, the | |||
| indication is restricted for replacement of | |||
| single lateral incisors in the maxilla and |
7
| | Narrow
Implant
System | | | Nobel Biocare
Replace™ Select | E | 3.5, 4.3,
5.0, 6.0 | 3.5, 4.3,
5.0, 6.0 | lateral and central incisors in the mandible.
The system consists of three major parts:
TiBase, inCoris mesostructured, and
CAD/CAM software. Specifically, the
inCoris mesostructured and TiBase
components make up a two-piece
abutment which is used in conjunction
with endosseoous dental implants to
restore the function and aesthetics in the
oral cavity. The inCoris mesostructured
may also be used in conjunction with the
Camlog Titanium base CAD/CAM(types
K2244.xxxx)(K083496) in the Camlog
Implant System. The CAD/CAM software
is intended to design and fabricate the
inCoris mesostructure. The inCoris
mesostructured and TiBase two-piece
abutment is compatible with the following
implants systems: |
|------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|-------------------------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | UF Sub
merged
Implant
System | 3.8/4.0/4.5/
5.0/5.5/6.0/
6.5/7.0 | 3.8/4.0/4.5/
5.0/5.5/6.0/
6.5/7.0 | Nobel Biocare
Nobel Active™ | F | 3.5, 4.3,
5.0 | 3.5, 3.9
(4.3), 3.9
(5.0) | |
| | UF(II)
Implant
System | 3.8/4.0/4.5/
5.0/5.5 | 3.8/4.0/4.5/
5.0/5.5 | Biomet 3i
Osseotite® | H | 3.25, 4.0,
5.0 | 3.4, 4.1,
5.0 | Nobel Biocare Replace(K020646) |
| | | | | Certain
Biomet 3i
Osseotite® | I | 3.25, 3.75,
4.0, 5.0 | 3.4, 4.1,
5.0 | Nobel Biocare Branemark(K022562) |
| | | | | Nobel Biocare
Branemark | K | 3.3, 3.75,
4.0, 5.0 | 3.5, 4.1,
4.1, 5.1 | Friadent Xive(K013867) |
| | | Patient specific abutment is intended for use with
the UF Implant Systems provided in the chart. All
digitally designed abutments for use with DIO
CAD/CAM Abutments are intended to be
manufactured at a DIO Corporation validated
milling center. | | Straumann Bone
Level | L | 3.3, 4.1,
4.8 | 3.3, 4.1,
4.8 | Biomet 3i Osseotite(K980549) |
| | | | | Straumann
Stnadard | N | 3.3, 4.1,
4.8 | 3.5(NNC),
4.8, 6.5 | Astra Tech Osseospeed(K091239) |
| | | | | Zimmer Tapered
Screw-vent® | R | 3.3, 3.7,
4.1, 4.7,
6.0 | 3.5, 4.5,
5.7 | Zimmer Tapered Screw-Vent(K061410) |
| | | | | Austra Tech
OsseoSpped™ | S | 3.5, 4.0,
4.5, 5.0 | 3.5, 4.0,
4.5, 5.0 | Straumann SynOcta(K061176) |
| | | | | Dentsply
Friadent®
Frialit/XiVE® | T | 3.4, 3.8,
4.5, 5.5 | 3.4, 3.8,
4.5, 5.5 | Straumann Bone Level(K053088,
K062129, K060958) |
| | | | | Dentsply
Friadent®
Ankylos® | Y | 3.5, 4.5,
5.5, 7.0 | 3.5, 4.5,
5.5, 7.0 | Biomet 3i Certain(K014235, K061629) |
| | | | | Medentika PreFace is intended for use with the
Straumann® CARES® System. All digitally designed
abutments for use with Medentika CAD/CAM Abutments
are intended to be manufactured at a Straumann®
CARES® validated milling center. | | | | Nobel Biocare Active(K071370) |
| Substantial
Equivalence
Comparison | | | | | | | | The subject Hybrid Link Abutment is substantially equivalent in designs, dimensions, material, indications, and technological characteristics
with the identified primary predicate device. The DIO CAD/CAM Abutment 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-food endosseous dental implants and endosseous dental implant abutments.
The diameters of the subject device are slightly different from the predicate devices. However, the subject diameters are in the range of
diameters of predicates and this dimensional difference doesn't affect device safety and effectiveness.
The Indications for Use of the subject and primary predicate device are identical other than the compatible implant bodies. This difference is
mitigated by fatigue testing, reverse engineering, dimensional analysis and identification of reference device for compatible implant bodies |
8
Both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor. Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.
2) Patient-Specific Abutment
| | Subject Device | Primary
Predicate Device | Reference Device | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Applicant | DIO Corporation | Medentika GmbH | Zimmer Dental, Inc. | BIOMET 3i |
| Trade Name | DIO CAD/CAM Abutment | Medentika CAD/CAM Abutment | Zimmer® patient
Specific Abutment,
Internal Hex, Titanium | Encode Patient
Specific Abutment for
Straumann Bone Level
Connection |
| 510(K) No. | Not yet assigned | K150203 | K143505 | K112730 |
| Classification
Name | Endosseous Dental Implant, Abutment
(872.3630) | Endosseous Dental Implant, Abutment
(872.3630) | Endosseous Dental
Implant, Abutment
(872.3630) | Endosseous Dental
Implant, Abutment
(872.3630) |
| Product Code | NHA | NHA | NHA | NHA |
| Class | II | II | II | II |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM
F136) | Ti-6Al-4V ELI
(ASTM F136) |
| Design | CAD/CAM Patient-Specific Abutment | CAD/CAM Blank | CAD/CAM Patient-
Specific Abutment | CAD/CAM Patient-
Specific Abutment |
| Diameters (mm) | CAD/CAM Patient-Specific Abutment
: 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 | 3.0-7.0 | 3.5/ 4.5/ 5.7 | 3.3/ 4.1/ 4.8 |
| Sterile | Steam Sterilization by user
(Provided Non-Sterile) | Steam Sterilization by user
(Provided Non-Sterile) | Steam Sterilization by
user
(Provided Non-Sterile) | Steam Sterilization by
user
(Provided Non-Sterile) |
| Type of Retention | Screw-retained or cement retained | Cement-retained | Screw-retained or
cement retained | Screw-retained or
cement retained |
| Abutment Seat | Sits on Taper | Sits on Taper | Sits on Taper | Sits on Taper |
| Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity | Oral Cavity |
| Constructions | Machined | Machined | Machined | Machined |
| Indications For
Use/
Intended Use | DIO CAD/CAM Abutment is intended for use
with dental implants as a support for single or
multiple tooth prostheses in the maxilla or | Medentika Preface CAD/CAM Abutments are intended
for use with dental implants as a support for single or
multiple tooth prostheses in the maxilla or mandible of | The Zimmer® Patient
Specific Abutment is
used as a terminal or | The 3i Patient-Specific
Dental Abutment is
intended for use as an |
9
| mandible of a partially or fully edentulous patient. | | | a partially or fully edentulous patient. | | | intermediate abutment
for a cemented
prosthesis. The
abutment can be used
for a single of multiple-
unit restoration. | accessory to an
endosseous dental
implant to support a
prosthetic device in a
partially or edentulous
patient. It is intended
for use to support
single and multiple
tooth prostheses, in the
mandible or maxilla.
The prostheses can be
screw or cement
retained to the
abutment. | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Implant
System
Compatibility | Implant
Diameter
(mm) | Platform
Diameter
(mm) | Implant System
Compatibility | Series | Implant
Diameter
(mm) | Platform
Diameter
(mm) | | |
| UF(II)
Narrow
Implant
System | 3.0/ 3.3 | 3.0/ 3.3 | Nobel Biocare
ReplaceTM Select | E | 3.5, 4.3, 5.0,
6.0 | 3.5, 4.3,
5.0, 6.0 | | |
| UF Sub
merged
Implant
System | 3.8/4.0/4.5/
5.0/5.5/6.0/
6.5/7.0 | 3.8/4.0/4.5/
5.0/5.5/6.0/
6.5/7.0 | Nobel Biocare
Nobel ActiveTM | F | 3.5, 4.3, 5.0 | 3.5, 3.9
(4.3), 3.9
(5.0) | | |
| | | | Biomet 3i
Osseotite®
Certain | H | 3.25, 4.0, 5.0 | 3.4, 4.1,
5.0 | | |
| | | | Biomet 3i
Osseotite® | I | 3.25, 3.75,
4.0, 5.0 | 3.4, 4.1,
5.0 | | |
| | | | Nobel Biocare
Branemark | K | 3.3, 3.75,
4.0, 5.0 | 3.5, 4.1,
4.1, 5.1 | | |
| UF(II)
Implant
System | 3.8/4.0/4.5/
5.0/5.5 | 3.8/4.0/4.5/
5.0/5.5 | Straumann Bone
Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1,
4.8 | | |
| | | | Straumann
Stnadard | N | 3.3, 4.1, 4.8 | 3.5(NNC),
4.8, 6.5 | | |
| | | | Zimmer Tapered
Screw-vent® | R | 3.3, 3.7, 4.1,
4.7, 6.0 | 3.5, 4.5,
5.7 | | |
| | | | Austra Tech
OsseoSppedTM | S | 3.5, 4.0, 4.5,
5.0 | 3.5, 4.0,
4.5, 5.0 | | |
| | | | Dentsply
Friadent®
Frialit/XiVE® | T | 3.4, 3.8, 4.5,
5.5 | 3.4, 3.8,
4.5, 5.5 | | |
| | | | Dentsply
Friadent®
Ankylos®
Medentika PreFace is intended for use with the
Straumann® CARES® System. All digitally designed
abutments for use with Medentika CAD/CAM
Abutments are intended to be manufactured at a
Straumann® CARES® validated milling center. | Y | 3.5, 4.5, 5.5,
7.0 | 3.5, 4.5,
5.5, 7.0 | | |
| Patient specific abutment is intended for use with the UF implant systems provided in the chart.
All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be
manufactured at a DIO Corporation validated milling center. | | | | | | | | |
| The subject Patient-Specific Abutment is substantially equivalent in designs, dimensions, material, indications, abutment seat, screw seat,
anatomical site, connection, and technological characteristics with the identified primary predicate device. The DIO CAD/CAM Abutment 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-food endosseous dental implants and endosseous dental
implant abutments. | | | | | | | | |
| Substantial
Equivalence
Comparison | Compared to the primary predicate device, the subject device different with predicate device design, the predicate device design is CAD/CAM | | | | | | | |
| | Blank and the subject device is patient specific device. To support this discrepancy of different component inclusion, K143505 and K112730 | | | | | | | |
| | were added as both predicates have the CAD/CAM patient specific abutment with equivalent design, dimensions, materials and indications. | | | | | | | |
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The Indications for Use of the subject and primary predicate device than the compatible implant bodies. This difference is mitigated by fatigue testing, reverse engineering, dimensional analysis, and identification of reference device for compatible implant bodies. Both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor. Any differences in technology characteristics are accompanied by information that device is substantially equivalent
as the predicate and do not raise different questions of safety and effectiveness than the predicate.
11
K181037
Non-clinical Testing
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- . Fatigue Tests according to ISO 14801:2016
- End User Steam Sterilization Tests according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010
- Cytotoxicity testing according to ISO 10993-5:2009
Below tests were performed for predicate devices. K122519 and leveraged for the subject device:
- Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-● 10:2010.
Biocompatibility test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device which is owned by the applicant. The results of the above tests have met the criteria of the standard and demonstrated the substantial equivalence with the predicate device.
Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing.
Clinical testing was not necessary to establish substantial equivalency of the device.
Conclusion
The DIO CAD/CAM Abutment constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, DIO CAD/CAM Abutment sand its predicates are substantially equivalent