(285 days)
No
The summary describes a physical dental abutment system and its mechanical testing, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device, a premilled titanium block system for dental abutments, is a prosthetic component for dental implants and does not actively treat or cure a disease or condition.
No
Explanation: The device description states it is a "Premilled Titanium Block System" used for "fabricating patient-specific abutments" to support prostheses. This describes a manufacturing component for dental restorations, not a device used to diagnose medical conditions or diseases.
No
The device description explicitly states it is a "Premilled Titanium Block System" and describes physical components made of "titanium alloy," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide support for dental prostheses in the maxilla or mandible of a patient. This is a direct clinical application within the body.
- Device Description: The device is a physical component (titanium block system) used to fabricate patient-specific abutments for dental implants. This is a medical device used in a surgical/restorative procedure.
- 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 screening.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use as part of a dental restoration.
N/A
Intended Use / Indications for Use
Premilled Titanium Block System 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
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 subject Premilled Titanium Block System has two types of blocks, Premilled Titanium Block (Hex, Non-Hex) and Magic Premilled Titanium Block (Hex, Non-hex) based on the compatible implant system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
The subject device was tested to evaluate its substantial equivalence according to the following standards.
-
Fatigue Tests on subject device under the worst-case scenario according to ISO 14801:2016 .
Below tests were performed for predicate devices and leveraged for the subject device: -
Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010 on abutments referenced in K152520 and K173120
-
End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K192197
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Non-clinical test data 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.
K140806, K152520, K153350, K162099, K173120, K192197
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 logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
InnoBioSurg Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K203344
Trade/Device Name: Premilled Titanium Block System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: July 20, 2021 Received: July 26, 2021
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/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 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.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203344
Device Name Premilled Titanium Block System
Indications for Use (Describe)
Premilled Titanium Block System 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) |
|---|---|---|
| IBS Implant System | 3.8/4.3/4.8/5.3/5.8/6.3 | 3.8/4.3/4.8/5.3/5.8/6.3 |
| IBS Implant System | 3.5/4.0/4.5/5.0/5.5/6.0/6.5 | 3.5/4.0/4.5/5.0/5.5/6.0/6.5 |
| Magicore System | 4.0/4.5/5.0/5.5/6.0/6.5 | 4.0/4.5/5.0/5.5/6.0/6.5 |
| IBS Implant System II | 3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5 | 3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5 |
Premilled Ttanium Block System is intended for use with the IBS implant system and IBS Implant System II in the chart. All digitally designed abutments for use with Premilled Titanium Block System are intended to be manufactured at a Innobiosurg 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) |
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
estimated 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
510(k) Summary
Submitter
InnoBioSurg Co., Ltd. Sun-Mi Park 44-19, Techno 10-ro, Yuseong-gu Daejeon, 34027 Republic of Korea Email: smpark@ibsimplant.com Tel. +82-42-933-2879 Fax. +82-42-933-2881
Device Information
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
- Trade Name: Premilled Titanium Block System
- Common Name: Dental Abutment System
- Classification Name: Endosseous dental implant abutment ●
- Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3630 ●
- Device Class: Class II
- Date prepared: 07/20/2021
Predicate Devices:
Primary Predicate
K181037, DIO CAD/CAM Abutment by DIO CORPORATION
Reference Device
K140806, IBS Implant System by InnoBioSurg Co., Ltd.
K152520, Magicore Systyem by InnoBioSurg Co., Ltd.
K153350, IBS Implant System by InnoBioSurg Co., Ltd.
K162099, IBS Implant System II by InnoBioSurg Co., Ltd.
K173120, CCM Abutment System by InnoBioSurg Co., Ltd.
K192197. Magicore II System by InnoBioSurg Co., Ltd.
Indication for Use:
Premilled Titanium Block System 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) |
|---|---|---|
| IBS Implant System | 3.8/4.3/4.8/5.3/5.8/6.3 | 3.8/4.3/4.8/5.3/5.8/6.3 |
| IBS Implant System | 3.5/4.0/4.5/5.0/5.5/6.0/6.5 | 3.5/4.0/4.5/5.0/5.5/6.0/6.5 |
| Magicore System | 4.0/4.5/5.0/5.5/6.0/6.5 | 4.0/4.5/5.0/5.5/6.0/6.5 |
| IBS Implant System II | 3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5 | 3.5/3.8/4.0/4.5/5.0/5.5/6.0/6.5 |
Premilled Titanium Block System is intended for use with the IBS implant system, Magicore System and IBS Implant System II in the chart. All digitally designed abutments for use with Premilled Titanium Block System are intended to be manufactured at a Innobiosurg validated milling center.
4
Device Description:
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 subject Premilled Titanium Block System has two types of blocks, Premilled Titanium Block (Hex, Non-Hex) and Magic Premilled Titanium Block (Hex, Non-hex) based on the compatible implant system.
| Patient-Specific
Abutment | Implant System
Compatibility | Compatible
Implants | Implant Diameter (mm) | Platform Diameter
(mm) |
|-----------------------------------------------------|---------------------------------|------------------------|-------------------------------------|-------------------------------------|
| Premilled Titanium
Block (Hex, Non-
Hex) | IBS Implant System | K140806 | 3.8/4.3/4.8/5.3/5.8/6.3 | 3.8/4.3/4.8/5.3/5.8/6.3 |
| Premilled Titanium
Block (Hex, Non-
Hex) | IBS Implant System | K153350 | 3.5/4.0/4.5/5.0/5.5/6.0/6.5 | 3.5/4.0/4.5/5.0/5.5/6.0/
6.5 |
| Hex) | IBS Implant System II | K162099 | 3.5/3.8/4.0/4.5/5.0/5.5/6.0/
6.5 | 3.5/3.8/4.0/4.5/5.0/5.5/
6.0/6.5 |
| Magic Premilled
Titanium Block
(Hex, Non-Hex) | Magicore System | K152520 | 4.0/4.5/5.0/5.5/6.0/6.5 | 4.0/4.5/5.0/5.5/6.0/6.5 |
Patient-Specific Abutment is compatible with following Implant Systems:
Patient-Specific Abutments are supplied with previous cleared abutment screws in K173120 and K140806 and provided non-sterile.
| Patient-Specific Abutment design Limitation (Unit :mm) | |||
|---|---|---|---|
| Block Type | Range (Diameter) | Range (Length) | Range (Angle) |
| Premilled Titanium Block (Hex, Non-Hex) | 4.2~6.5 | 3.0~14.0 | 0~30° |
| Magic Premilled Titanium Block | |||
| (Hex, Non-Hex) | 4.7~6.5 | 3.0~12.0 | 0~25° |
Manufacturing Parameters:
-
- Premilled Titanium Block
-Minimum and Maximum Gingival Height is 0.5-7.0mm.
- Premilled Titanium Block
-
Minimum diameter at abutment/implant interface is 2.485 to interface base
-
Maximum length of abutment from abutment/implant interface is 14.0 mm (Space allocated for each abutment along the titanium rod)
-
Minimum length of abutment post (length above the abutment collar/gingival height) is 4mm
-
Minimum wall thickness at abutment/implant interface is 0.517mm
-
Patient specific abutment compatible with Premilled Titanium Block has a maximum angle of 30.00
-
- Magic Premilled Titanium Block
- Minimum and Maximum Gingival Height is 0-7.0mm.
- Minimum diameter at abutment/implant interface is 2.485 to interface base
- Maximum length of abutment from abutment/implant interface is 12.0 mm (Space allocated for each abutment along the titanium rod)
- Minimum length of abutment post (length above the abutment collar/gingival height) is 4mm
- Minimum wall thickness at abutment/implant interface is 0.62mm
- Patient specific abutment compatible with Magic Premilled Titanium Block has a maximum angle of 25.0°
Materials:
- . Patient-specific abutment is fabricated from Ti-6A1-4V Eli (Conforming to ASTM Standard F136).
5
Summaries of Technology Characteristics
The subject device is substantially equivalent to the current cleared devices. They are substantially equivalent in intended use, material and connection interfaces to the implants are individual diameter and connection type. Comparison demonstrating Substantial Equivalence follows:
| Subject Device | Primary Predicate Device | ||||||
|---|---|---|---|---|---|---|---|
| Applicant | InnoBioSurg Co., Ltd. | DIO Corporation | |||||
| Trade Name | Premilled Titanium Block System | DIO CAM/CAM Abutment | |||||
| 510(k) No. | Not yet assigned | K181037 | |||||
| Classification Name | Endosseous Dental Implant, Abutment (872.3630) | Endosseous Dental Implant, Abutment (872.3630) | |||||
| Product Code | NHA | NHA | |||||
| Class | II | II | |||||
| Material | Ti-6AL-4V ELI (ASTM F136) | Ti-6AL-4V ELI (ASTM F136) | |||||
| Diameter (mm) | CAD/CAM Patient-Specific Abutment: | ||||||
| 3.5/3.8/4.0/4.8/4.8/5.0/5.3/5.5/5.8/6.0/6.3/6.5 | 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 | |||||||
| Sterile | Steam Sterilization by user | ||||||
| (Provided Non-Sterile) | Steam Sterilization by user | ||||||
| (Provided Non-Sterile) | |||||||
| Type of Retention | Screw-retained or cement retained | Screw-retained or cement retained | |||||
| Abutment Seat | Sits on Taper | Sits on Taper | |||||
| Anatomical Site | Oral Cavity | Oral Cavity | |||||
| Constructions | Machined | Machined | |||||
| Premilled Titanium Block System 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. | 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. | ||||||
| Indications For Use/ | |||||||
| Intended Use | Implant System | ||||||
| Compatibility | Implant Diameter | ||||||
| (mm) | Platform Diameter | ||||||
| (mm) | Implant System | ||||||
| Compatibility | Implant Diameter | ||||||
| (mm) | Platform Diameter | ||||||
| (mm) | |||||||
| IBS Implant | |||||||
| System | 3.8/4.3/4.8/5.3/5.8/6.3 | 3.8/4.3/4.8/5.3/5.8/6.3 | UF(II) Narrow | ||||
| Implant System | 3.0/3.3 | 3.0/3.3 | |||||
| IBS Implant | |||||||
| System | 3.5/4.0/4.5/5.0/5.5/6.0/ | ||||||
| 6.5 | 3.5/4.0/4.5/5.0/5.5/6.0/ | ||||||
| 6.5 | 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 | |||||||
| Magicore | |||||||
| System | 4.0/4.5/5.0/5.5/6.0/6.5 | 4.0/4.5/5.0/5.5/6.0/6.5 | UF(II) Implant | ||||
| System | 3.8/4.0/4.5/5.0/5.5 | 3.8/4.0/4.5/5.0/5.5 | |||||
| IBS Implant | |||||||
| System II | 3.5/3.8/4.0/4.5/5.0/5.5/ | ||||||
| 6.0/6.5 | 3.5/3.8/4.0/4.5/5.0/5.5/ | ||||||
| 6.0/6.5 | Patient specific abutment is intended for use with the UF implant system provided in the chart. All digitally designed abutments for use with DIO | ||||||
| Premilled Titanium Block System is intended for use with the IBS implant system, Magicore System and IBS Implant System II in the chart. All digitally designed abutments for use with Premilled Titanium Block |
6
| System are intended to be manufactured at a Innobiosurg validated milling center. | CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center. | |
|---|---|---|
| Substantial | ||
| Equivalence | ||
| Comparison | 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 patient specific 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 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, 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 demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate. |
7
Non-Clinical Testing
The subject device was tested to evaluate its substantial equivalence according to the following standards.
-
Fatigue Tests on subject device under the worst-case scenario according to ISO 14801:2016 .
Below tests were performed for predicate devices and leveraged for the subject device: -
Biocompatibility testing according to ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, ● and ISO 10993-10:2010 on abutments referenced in K152520 and K173120
-
End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 referenced in K192197
The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device.
Non-clinical test data 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 Premilled Titanium Block System 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 devices. Therefore, the Premilled Titanium Block System and its predicates are substantially equivalent.