(90 days)
No
The description focuses on the physical characteristics, materials, and manufacturing process (CAD/CAM and milling) of dental abutments. There is no mention of AI or ML being used in the design, manufacturing, or function of the device.
No.
The device, Pre-Milled Blank abutments, is intended to support dental prosthetic restorations by attaching to dental implants. Its function is structural and mechanical, not therapeutic.
No
Explanation: The device is a dental implant abutment system, the purpose of which is to provide support for customized prosthetic restorations, not to diagnose medical conditions.
No
The device description clearly states that the device is a system of dental implant abutments made from Ti-6Al-4V ELI (Grade 23) titanium, which are physical components. The summary also details non-clinical performance studies related to sterilization, biocompatibility, reverse engineering of physical parts, and static/fatigue testing, all indicative of a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "attachment to dental implants in order to provide support for customized prosthetic restorations." This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical characteristics, materials, and compatibility with dental implant systems. It focuses on the structural and mechanical aspects of the device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing information for diagnosis or monitoring of a disease or condition.
- Performance Studies: The performance studies focus on sterilization, biocompatibility, compatibility with implant systems, and mechanical testing (static and fatigue). These are typical evaluations for medical devices, but not for IVDs which would involve analytical and clinical performance related to diagnostic accuracy.
In summary, the ARUM Dentistry Pre-Milled Blank abutments are a type of dental prosthetic component, which falls under the category of medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
ARUM Dentistry's Pre-Milled Blank abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Pre-Milled Blank abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The customized Pre-Milled Blank abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw.
ARUM Dentistry's Pre-Milled Blanks are compatible with the implant systems listed in the Compatibility Table:
| ARUM Pre-Milled Blank | Implant Platform compatibility | Restorative Platform diameter [mm] | Implant Body diameter [mm] | Abutment Screw | |
|---|---|---|---|---|---|
| Ø10 mm | Ø14 mm | ||||
| CIHE037 | CIHE038 | NobelActive NP | 3.5 | 3.5 | CSTO001 |
| CIHE039 | CIHE040 | NobelActive RP | 3.9 | 4.3/5.0 | CSTO002 |
| CIHE135 | CIHE136 | NobelActive WP | 5.1 | 5.5 | CSTO002 |
All digitally-designed Pre-Milled Blank abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.
Product codes
NHA
Device Description
ARUM Dentistry Co., Ltd.'s Pre-Milled Blank abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the Reference device OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant interface connection interface with a customizable cylindrical section above the implant/abutment interface. The compatible implant body diameters range from 3.5 to 5.5 mm, with restorative interface diameters ranging from 3.0 to 5.1 mm (NP, RP and WP diameters).
The Subject device abutments and corresponding abutment screws are all pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided non-sterile to the user.
The Subject device abutments are in two customizable-section diameters for each restorative interface. The cylindrical section of the Subject device abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed custom abutments from titanium blank abutments are to be sent to an ARUM Dentistry Co., Ltd.-validated milling center for manufacture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 performance data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1, ISO 17665-2, and ISO 14937; biocompatibility according to ISO 10993-5 and ANSI/AAMI ST72; reverse engineering of the OEM implant bodies, OEM abutments and OEM abutment screws to confirm compatibility; static and fatigue testing according to ISO 14801. No clinical data is included in this submission.
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 9, 2020
ARUM Dentistry Co. Ltd % Chris Brown Manager Aclivi. LLC 6455 Farley Road Pinckney, Michigan 48169
Re: K193425
Trade/Device Name: Pre-Milled Blank Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: November 27, 2019 Received: December 10, 2019
Dear Chris Brown:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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.
for
Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Pre-Milled Blank
Indications for Use (Describe)
ARUM Dentistry's Pre-Milled Blank abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Pre-Milled Blank abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The customized Pre-Milled Blank abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw.
ARUM Dentistry's Pre-Milled Blanks are compatible with the implant systems listed in the Compatibility Table:
| Compatibility Table | |||||
|---|---|---|---|---|---|
| ARUM Pre-Milled Blank | Implant Platform | ||||
| compatibility | Restorative Platform | ||||
| diameter [mm] | Implant Body | ||||
| diameter [mm] | Abutment | ||||
| Screw | |||||
| Ø10 mm | Ø14 mm | ||||
| CIHE037 | CIHE038 | NobelActive NP | 3.5 | 3.5 | CSTO001 |
| CIHE039 | CIHE040 | NobelActive RP | 3.9 | 4.3/5.0 | CSTO002 |
| CIHE135 | CIHE136 | NobelActive WP | 5.1 | 5.5 |
All digitally-designed Pre-Milled Blank abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.
| 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."
3
K193425 - 510(k) Summary ARUM Dentistry Co., Ltd. Pre-Milled Blank 3/9/2020
5.1 ADMINISTRATIVE INFORMATION
Manufacturer Name ARUM Dentistry Co., Ltd. 1 Building, 44, Techno 8-ro, Yuseong-gu, Daejeon, 34028 Republic of Korea
Phone: +82-42-721-3644 Fax: +82-42-721-3645
| Official Contact | Heung-Yeon Hwang, Quality Manager |
|---|---|
| Email: | hwanghy@arumdentistry.com |
5.2 DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | Pre-Milled Blank |
|---|---|
| Common Name: | Abutment, Implant, Dental, Endosseous |
| Classification Name: | Endosseous dental implant abutment |
| Classification Regulation: | 21 CFR 872.3630 |
| Device Class: | Class II |
| Product Code: | NHA |
| Review Panel: | Dental Products Panel |
| Reviewing Branch: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1) |
| Dental Devices (DHT1B) |
5.3 PREDICATE DEVICE INFORMATION
The devices within this submission are substantially equivalent in indications, intended use and design principles to the following primary predicate and reference devices:
| Primary Predicate | ||
|---|---|---|
| 510(k) | Device Name | Company Name |
| K190299 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S |
| Reference Device | ||
| 510(k) | Device Name | Company Name |
| K071370 | NobelActive Internal Connection Implant | Nobel Biocare |
Primary Predicate
5.4 DEVICE DESCRIPTION
ARUM Dentistry Co., Ltd.'s Pre-Milled Blank abutments are a system of dental implant abutments which have an implant /abutment interface design compatible with the Reference device OEM Nobel Biocare NobelActive implant system. Each Subject device implant abutment has a pre-manufactured implant interface connection interface with a customizable cylindrical section above the implant/abutment interface. The compatible implant body diameters range from 3.5 to 5.5 mm, with restorative interface diameters ranging from 3.0 to 5.1 mm (NP, RP and WP diameters).
The Subject device abutments and corresponding abutment screws are all pre-manufactured from Ti-6Al-4V ELI (Grade 23) titanium conforming to ASTM F136 and provided non-sterile to the user.
The Subject device abutments are in two customizable-section diameters for each restorative interface 510k Summary 5- 1
4
The cylindrical section of the Subject device abutments are intended to be customized by means of CAD/CAM technology to provide basis or support for single or multiple tooth prosthetic restorations. All digitally designed custom abutments from titanium blank abutments are to be sent to an ARUM Dentistry Co., Ltd.-validated milling center for manufacture.
5.5 INDICATIONS FOR USE
ARUM Dentistry's Pre-Milled Blank abutments are intended for attachment to dental implants in order to provide support for customized prosthetic restorations. Pre-Milled Blank abutments are indicated for screw-retained single restorations or cement-retained single or multi-unit restorations. The customized Pre-Milled Blank abutment will be attached to a dental implant using the included ARUM Dentistry prosthetic screw.
ARUM Dentistry's Pre-Milled Blanks are compatible with the implant systems listed in the Compatibility Table:
| ARUM Pre-Milled Blank | | Implant Platform
compatibility | Restorative Platform
diameter [mm] | Implant Body
diameter [mm] | Abutment
Screw |
|-----------------------|---------|-----------------------------------|---------------------------------------|-------------------------------|-------------------|
| Ø10 mm | Ø14 mm | | | | |
| CIHE037 | CIHE038 | NobelActive NP | 3.5 | 3.5 | CSTO001 |
| CIHE039 | CIHE040 | NobelActive RP | 3.9 | 4.3/5.0 | CSTO002 |
| CIHE135 | CIHE136 | NobelActive WP | 5.1 | 5.5 | CSTO002 |
aatihility Tahla
All digitally-designed Pre-Milled Blank abutments are intended to be sent to an ARUM Dentistry-validated milling center for manufacture.
EQUIVALENCE TO MARKETED DEVICE 5.6
The Subject device is substantially equivalent to the predicate device with respect to Indications for Use and technological principles. The Comparison tables below compare the Indications for Use and Technological Characteristics of the Subject and Predicate devices.
| Device | Indications for Use Statement | |||||
|---|---|---|---|---|---|---|
| Subject Device | ||||||
| Pre-Milled Blank | ||||||
| ARUM Dentistry | ||||||
| Co., LTD | ARUM Dentistry's Pre-Milled Blank abutments are intended for attachment to dental implants in order to provide | |||||
| support for customized prosthetic restorations. Pre-Milled Blank abutments are indicated for screw-retained single | ||||||
| restorations or cement-retained single or multi-unit restorations. The customized Pre-Milled Blank abutment will be | ||||||
| attached to a dental implant using the included ARUM Dentistry prosthetic screw. | ||||||
| ARUM Dentistry's Pre-Milled Blanks are compatible with the implant systems listed in the Compatibility Table: | ||||||
| Compatibility Table | ||||||
| ARUM Pre-Milled Blank | Implant Platform | |||||
| compatibility | Restorative Platform | |||||
| diameter [mm] | Implant Body | |||||
| diameter [mm] | Abutment Screw | |||||
| Ø10 mm | Ø14 mm | |||||
| CIHE037 | CIHE038 | NobelActive NP | 3.5 | 3.5 | CSTO001 | |
| CIHE039 | CIHE040 | NobelActive RP | 3.9 | 4.3/5.0 | CSTO002 | |
| CIHE135 | CIHE136 | NobelActive WP | 5.1 | 5.5 | ||
| All digitally-designed Pre-Milled Blank abutments are intended to be sent to an ARUM Dentistry-validated milling | ||||||
| center for manufacture. | ||||||
| Primary | ||||||
| Predicate | ||||||
| Elos Accurate | ||||||
| Customized | ||||||
| Abutment | ||||||
| (K190299) | The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for | |||||
| single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental | ||||||
| implant using the included Elos Prosthetic screw. | ||||||
| The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1: | ||||||
| Table 1. |
Comparison of Indications for Use Statements
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| Device | Indications for Use Statement | |||
|---|---|---|---|---|
| Elos Medtech | ||||
| Pinol A/S | Elos Accurate | |||
| Customized | ||||
| Abutment - Model Type | Platform compatibility | Platform | ||
| diameter | ||||
| [mm] | Implant Body | |||
| diameter | ||||
| [mm] | ||||
| AB-NBR35 | Nobel Replace NP | 3.5 | 3.5 | |
| AB-NBA30 | Nobel CC 3.0 | 3.0 | 3.0 | |
| AB-NBA43 | Nobel CC RP | 3.9 | 4.3 & 4.5 | |
| AB-NBA60 | Nobel CC WP | 5.1 | 5.5 | |
| AB-SBO33 | Straumann Bone Level NC | 3.3 | 3.3 | |
| AB-SBO41 | Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |
Except for the device name, reference/model numbers, the list of specific compatible platforms, and company approving the milling facility the Subject and Predicate devices have nearly identical Indications for Use. These differences do not change the intended use of the Subject and Predicate devices to provide support for single or multi-unit prosthetic restorations. The slight differences in the wording "attachment to dental implants in order to provide support for" and "attaching to dental implants in order to provide basis for" are simply different ways to describe the same intended use. The inclusion of the language "screw-retained single restoration and cement-retained single or multi-unit restoration" specifies sub-sets of the types of single and multi-unit restorations included in the primary predicate. Identifying the specific types of single and multi-unit restorations does not change the intended use of the device.
| Design Parameter | Subject Device | Primary Predicate | Equivalence Discussion |
|---|---|---|---|
| Pre-Milled Blanks | |||
| ARUM Dentistry Co., Ltd | Elos Accurate Customized Abutment | ||
| (K190299) | |||
| FDA Classification & | |||
| Product Code | Endosseous dental implant abutment, | ||
| 21 CFR 872.360, NHA | Endosseous dental implant abutment, | ||
| 21 CFR 872.360, NHA | Substantially Equivalent | ||
| Materials | Titanium Ti-6Al-4V ELI | Titanium Ti-6Al-4V ELI | Substantially Equivalent |
| Surface Finish | Non-coated | Non-coated | |
| Optional DLC coating on screws | Substantially Equivalent | ||
| The optional coating does not change | |||
| the intended use of the device. | |||
| Implant Interface | Indexed | Indexed | Substantially Equivalent |
| Connection type | Conical | Flat top and conical | Substantially Equivalent |
| Different connection interfaces do | |||
| not change the intended use of the | |||
| device. | |||
| Abutment Interface | |||
| diameter | 3.5-5.1 mm | 3.0-6.0 mm | Substantially Equivalent |
| Slight differences in interface | |||
| diameters do not change the | |||
| intended use of the device. | |||
| Prosthesis Attachment | Cement-retained | Cement-retained | Substantially Equivalent |
| Restoration | Single-unit & Multi-Unit | Single-unit & Multi-Unit | Substantially Equivalent |
| Mode of operation | Provide support for single and multi- | ||
| unit prostheses. | Provide support for single and multi- | ||
| unit prostheses. | Substantially Equivalent | ||
| Sterility | Provided non-sterile | Provided non-sterile | Substantially Equivalent |
| Sterilization method | Steam Sterilization | Steam sterilization | Substantially Equivalent |
| Abutment Design | |||
| Parameters | Minimum wall thickness: 0.5 mm | ||
| Maximum post height: 13 mm | |||
| Maximum angulation: 30° | |||
| Maximum diameter: 14 mm | |||
| Minimum post height: 4 mm | |||
| Minimum gingiva height: 0.5 mm | |||
| Maximum gingiva height: 4 mm | Minimum wall thickness: 0.4 mm | ||
| Maximum post height: 13 mm | |||
| Maximum angulation: 30° | |||
| Maximum diameter: 12 mm | |||
| Minimum post height: 4 mm | |||
| Minimum gingiva height: 0.5 mm | |||
| Maximum gingiva height: 5mm | Substantially Equivalent | ||
| A slightly larger minimum wall | |||
| thickness, and slightly smaller | |||
| maximum gingival height of the | |||
| Subject device does not change the | |||
| intended use of the device. |
Comparison of Technological Characteristics
Minor differences in abutment interface geometry due to compatible implant systems or restorative interface diameters do not introduce new risk nor change the intended use of the device to provide support for single and multi-unit prosthetic restorations.
6
Overall, the Technological Characteristics, mode of operation and materials of the Subject device are substantially equivalent to that of the Predicate device.
5.7 NON-CLINICAL PERFORMANCE DATA
Non-clinical performance data submitted to demonstrate substantial equivalence included: sterilization validation according to ISO 17665-1, ISO 17665-2, and ISO 14937; biocompatibility according to ISO 10993-5 and ANSI/AAMI ST72; reverse engineering of the OEM implant bodies, OEM abutments and OEM abutment screws to confirm compatibility; static and fatigue testing according to ISO 14801. No clinical data is included in this submission.
5.8 CONCLUSION
Slight variations in the wording of the Indications for the Subject and Predicate devices do not change the intended use of the devices to provide support for single or multi-unit prosthetic restorations.
Slight differences in the compatible implant system abutments available in the Subject and Predicate device systems does not change the intended use of the devices to provide support for single or multi-unit prosthetic restorations.
The slight differences in the Technological Characteristics of the Subject and Predicate devices do not change the intended use of the devices to provide support for single or multi-unit prosthetic restorations or introduce new risk or concerns. Differences in Subject device abutment design parameters were validated with respect to intended use through Performance testing.
Overall, the Pre-Milled Blank Subject device is substantially equivalent to the Predicate device.