(139 days)
No
The submission focuses on changing the sterilization method of existing prosthetic components and does not mention any AI/ML capabilities.
No
The device, Healing Abutments and Cover Screws, are described as accessories used provisionally during dental implant healing to aid in tissue contouring and protect implant features, rather than directly treating or preventing a disease or condition. They are prosthetics used in rehabilitation.
No
The device description clearly states its purpose is to change the sterilization method for "Healing Abutments and Cover Screws," which are "used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutment" and "to protect the inner features of the implant," respectively. These functions are therapeutic and supportive of a prosthetic procedure, not diagnostic.
No
The device description clearly states that the device is a physical object (Healing Abutments and Cover Screws made of Ti-6Al-4V ELI) and the submission is related to a change in its sterilization method. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid in prosthetic rehabilitation." This describes a surgical and restorative procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description clearly states that the devices are "Healing Abutments and Cover Screws" used provisionally during the healing period after implant placement. These are physical components used in a surgical procedure.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on sterilization validation, shelf life, and biocompatibility – all relevant to a medical device used in a surgical context, but not to an IVD.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
Product codes
NHA
Device Description
The Healing Abutments and Cover Screws are prefabricated and made of Ti-6Al-4V ELI (ASTM F136). These devices are sterilized using gamma radiation method and intended for single use only.
Healing Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutment. Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final abutment. Cover Screws are used provisionally as an accessory to protect the inner features of the implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone of the upper or lower jaw arche
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
· Gamma radiation sterilization validation according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6.
· Accelerated and real time aging studies according to ASTM F1980 demonstrating a shelf life.
· Biocompatibility of Ti-6A1-4V ELI (ASTM F136) demonstrated by the referenced Dentium submission, K041368, using the identical materials and manufacturing processes including sterilization as the subject 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.
K041368, K112045, K141457, K153268, K172640
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.
January 23, 2020
Dentium Co., Ltd. Byung-Sun Kim RA Team Manager 150, Eondong-ro Giheung-gu Yongin-si 446-914 REPUBLIC OF KOREA
Re: K192436
Trade/Device Name: Healing Abutments and Cover Screws Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 21, 2020 Received: January 23, 2020
Dear Byung-Sun Kim:
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
Indications for Use
510(k) Number (if known) K192436
Device Name Healing Abutments and Cover Screws
| Indications for Use (Describe) | Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation. |
|---|---|
| -------------------------------- | ---------------------------------------------------------------------------------- |
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 |
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
1. Company
| Submitter | |
|---|---|
| Name | Dentium Co., Ltd. |
| Address | 150, Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Korea (16985) |
| Phone/Fax | Tel. +82-70-7098-8806, Fax. +82-31-8019-9131 |
| Contact person | Byung-sun Kim / RA |
| bskim@dentium.com | |
| Summary Date | 01/17/2020 |
2. Device Name
| Proprietary name | : Healing Abutments and Cover Screws |
|---|---|
| Regulation number | : 21 CFR 872.3630 |
| Regulation Description | : Endosseous dental implant abutment |
| Product code | : NHA |
| Device class | : Class II |
| Classification Panel | : Dental Products Panel |
| Reviewing Branch | : Dental Devices Branch |
3. Predicate Device
Primary Predicate
K052957 Implantium Abutments
Reference Predicate
| K041368 | Implantium |
|---|---|
| K112045 | SimpleLine II Abutment System |
| K141457 | Dentium Implantium® and SuperLine® Abutment |
| K153268 | NR Line Implant System |
4
Dentium Implantium & SuperLine Prosthetics K172640
4. Indication for use
Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.
5. Description
The purpose of this submission is to change the sterilization method of Healing Abutments and Cover Screws. These devices which have been provided non-sterilized by gamma radiation.
Healing Abutments are used provisionally as an accessory to endosseous dental implant during healing period to prepare gingival tissue for acceptance of a final abutment. Healing Abutments are designed to aid in soft tissue contouring during the healing period after implant placement, creating an emergence profile for the final abutment. Cover Screws are used provisionally as an accessory to protect the inner features of the implant.
The Healing Abutments and Cover Screws are prefabricated and made of Ti-6Al-4V ELI (ASTM F136). These devices are sterilized using gamma radiation method and intended for single use only.
6. Performance Data
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included:
· Gamma radiation sterilization validation according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6.
- · Accelerated and real time aging studies according to ASTM F1980 demonstrating a shelf life.
· Biocompatibility of Ti-6A1-4V ELI (ASTM F136) demonstrated by the referenced Dentium submission, K041368, using the identical materials and manufacturing processes including sterilization as the subject device.
5
7. Technological Characteristics
The following comparison table of the technological characteristics of the subject device and the predicate devices outlines and provides the similarities and the substantial equivalency of the subject device and the predicate.
7.1 Healing Abutment
| | Subject device | Primary
Predicate | Reference predicate | | | |
|-----------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Device name | Healing
Abutments and
Cover Screws | Implantium
Abutments
(Healing
Abutment) | Implantium
(Healing
Abutment) | SimpleLine II
Abutment
System
(Healing
Abutment) | NR Line
Implant System
(Healing
Abutment) | Dentium
Implantium &
SuperLine
Prosthetics
(Healing
Abutment) |
| Manufacturer | Dentium Co.,
Ltd. | Dentium Co.,
Ltd. | Dentium Co.,
Ltd. | Dentium Co.,
Ltd. | Dentium Co.,
Ltd. | Dentium Co.,
Ltd. |
| 510(k) Number | K192436 | K052957 | K041368 | K112045 | K153268 | K172640 |
| Indication for
use | Dentium
Prosthetics are
intended for use
as an aid in
prosthetic
rehabilitation. | Implantium
Prosthetics is
intended for use
as an aid in
prosthetic
rehabilitation. | The Dentium
Co Ltd
Implantium is
intended to be
surgically
placed in the
bone of the
upper or lower
jaw arches to
provide support
for prosthetic
devices, such as
artificial
teeth, and to
restore the
patient's
chewing
function. | The SimpleLine
II Abutment
system is
intended for use
as an aid in
prosthetic
rehabilitation. | The NR Line
Implants
System is
indicated for
use in surgical
and restorative
applications for
placement in
the bone of the
upper or lower
jaw to provide
support for
prosthetic
devices, such as
artificial teeth,
in order to
restore the
patient's
chewing
function. NR
Line Implant
System is
indicated also
for immediate
loading when | Dentium
Implantium® &
SuperLine®
Prosthetics are
intended for use
as an aid in
prosthetic
rehabilitation. |
Comparison of Characteristics
510(k) Summary
6
| | | | | | | good primary
stability is
achieved and
with
appropriate
occlusal
loading. | |
|--------------------|---------------------------------|------------------------------|---------------------------------|------------------------------|------------------------------|---------------------------------------------------------------------------------------------|--|
| Materials | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) | |
| Form | Preformed | Preformed | Preformed | Preformed | Preformed | Preformed | |
| Connection
type | Internal | Internal | Internal | Internal | Internal | Internal | |
| Sterilization | Sterile
(Gamma
Radiation) | Non-sterile | Sterile
(Gamma
Radiation) | Non-sterile | Non-sterile | Non-sterile | |
| Use | Prescription | Prescription | Prescription | Prescription | Prescription | Prescription | |
| Single Use Only | Yes | Yes | Yes | Yes | Yes | Yes | |
Dimension comparison
| Image | Dimension (mm) | ||
|---|---|---|---|
| Subject device | |||
| (K192436) | Image: implant | Diameter | 4.04 / 4.10 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.54 / 5.64 / 5.75 / |
| 6.50 / 6.54 / 6.64 / 6.75 / 7.64 / 8.64 / 9.64 | |||
| Length | 8.70 / 10.91 / 10.93 / 11.04 / 11.15 / 12.41 / 12.44 / 12.55 / 12.65 / 12.66 / | ||
| 14.42 / 14.44 / 14.55 / 14.66 | |||
| Image: implant | Diameter | 4.16 / 4.53 / 5.02 / 5.23 / 6.22 / 6.43 | |
| Length | 10.52 / 10.55 / 12.26 / 12.28 / 14.25 / 14.27 | ||
| Image: implant | Diameter | 4.80 / 6.50 | |
| Length | 6.15 / 6.30 / 7.15 / 7.30 / 8.15 / 8.30 / 9.15 / 9.30 | ||
| Image: implant | Diameter | 3.70 / 4.30 / 5.50 / 6.50 / 7.50 / 8.50 / 9.50 | |
| Length | 8.10 / 8.60 / 10.10 / 12.10 | ||
| Image: implant | Diameter | 4.04 / 4.12 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.45 / 5.64 / 5.75 / | |
| 6.50 / 6.54 / 6.64 / 6.74 / 7.54 / 7.64 / 8.54 / 8.64 / 9.54 / 9.64 | |||
| Length | 8.88 / 8.89 / 8.90 / 10.81 / 10.83 / 10.96 / 11.05 / 11.06 / 11.09 / 12.31 / 12.34 / | ||
| 12.45 / 12.55 / 12.56 / 12.57 / 14.32 / 14.34 / 14.51 / 14.56 | |||
| Predicate device | |||
| K052957 | Image: implant | Diameter | 4.04 / 4.10 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.54 / 5.64 / 5.75 / |
| 6.50 / 6.54 / 6.64 / 6.75 / 7.64 / 8.64 / 9.64 | |||
| Length | 8.70 / 10.91 / 10.93 / 11.04 / 11.15 / 12.41 / 12.44 / 12.55 / 12.65 / 12.66 / | ||
| 14.42 / 14.44 / 14.55 / 14.66 |
510(k) Summary
Page 4 of 8
7
K192436
| K041368 | Image: dental implant | Diameter | 4.16 / 4.53 / 5.02 / 5.23 / 6.22 / 6.43 |
|---|---|---|---|
| Length | 10.52 / 10.55 / 12.26 / 12.28 / 14.25 / 14.27 | ||
| K112045 | Image: dental implant | Diameter | 4.80 / 6.50 |
| Length | 6.15 / 6.30 / 7.15 / 7.30 / 8.15 / 8.30 / 9.15 / 9.30 | ||
| K153268 | Image: dental implant | Diameter | 3.70 / 4.30 / 5.50 / 6.50 / 7.50 / 8.50 / 9.50 |
| Length | 8.10 / 8.60 / 10.10 / 12.10 | ||
| K172640 | Image: dental implant | Diameter | 4.04 / 4.12 / 4.14 / 4.20 / 4.50 / 4.54 / 4.64 / 4.70 / 5.50 / 5.45 / 5.64 / 5.75 / |
| 6.50 / 6.54 / 6.64 / 6.74 / 7.54 / 7.64 / 8.54 / 8.64 / 9.54 / 9.64 | |||
| Length | 8.88 / 8.89 / 8.90 / 10.81 / 10.83 / 10.96 / 11.05 / 11.06 / 11.09 / 12.31 / 12.34 | ||
| 12.45 / 12.55 / 12.56 / 12.57 / 14.32 / 14.34 / 14.51 / 14.56 |
1) Similarities
The subject Healing Abutments have the same characteristics for the followings compared to the primary predicate device.
- Indication for use, Material, Connection type, Dimension
The subject Healing Abutments have the same dimensions cleared under K052957. K041368. K112045, K153268 and K172640.
2) Differences
The subject Healing Abutments have the different characteristic for the following compared to the primary predicate device.
- Sterilization Method
3) Discussion
The purpose of this submission is to change the sterilization method of Healing Abutments previously cleared under K052957, K041368, K112045, K153268 and K172640. These Healing Abutments which have been provided non-sterile will be sterilized by gamma radiation. In terms of sterilization method there is difference between the subject device and primary predicate device. However, the reference device K041368 is sterilized via gamma radiation as the subject device. And the sterilization method of subject device was validated according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6
In conclusion, the subject device is substantially equivalent to the predicate device because it is verified that the difference does not affect substantial equivalence.
8
7.2 Cover Screw
Comparison of Characteristics
| | Primary
Subject device
Predicate | | Reference predicate | | |
|-----------------------|-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Device name | Cover Screw | Implantium
(Cover Screw) | SimpleLine II
Abutment System
(Cover Screw) | NR Line Implant
System
(Cover Screw) | Dentium
Implantium® and
SuperLine®
Abutments
(Cover Screw) |
| Manufacturer | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. | Dentium Co., Ltd. |
| 510(k) Number | K192436 | K052957 | K112045 | K153268 | K141457 |
| Indication for
use | Dentium
Prosthetics are
intended for use as
an aid in
prosthetic
rehabilitation. | Implantium
Prosthetics is
intended for use as
an aid in
prosthetic
rehabilitation. | The SimpleLine II
Abutment system
is intended for use
as an aid in
prosthetic
rehabilitation. | The NR Line
Implants System
is indicated for use
in surgical and
restorative
applications for
placement in the
bone of the
upper or lower jaw
to provide support
for prosthetic
devices, such as
artificial teeth, in
order to restore the
patient's
chewing function.
NR Line Implant
System is
indicated also for
immediate loading
when good
primary stability is
achieved and with
appropriate
occlusal loading. | Dentium
Prosthetics are
intended for use as
an aid in
prosthetic
rehabilitation. |
| Materials | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) | Ti-6Al-4V ELI
(ASTM F136) |
| Form | Preformed | Preformed | Preformed | Preformed | Preformed |
| Sterilization | Sterile
(Gamma
Radiation) | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Use | Prescription | Prescription | Prescription | Prescription | Prescription |
| Single Use Only | Yes | Yes | Yes | Yes | Yes |
510(k) Summary
9
Dimension comparison
| Image | Dimension (mm) | ||
|---|---|---|---|
| Subject device | |||
| (K192436) | Image: dental implant | Diameter | 3.18 / 3.37 / 4.12 |
| Length | 6.36 / 6.88 / 8.92 | ||
| Image: dental implant | Diameter | 3.10 / 3.50 | |
| Length | 4.70 / 5.70 | ||
| Image: dental implant | Diameter | 3.50 / 4.30 | |
| Length | 5.40 / 5.75 | ||
| Image: dental implant | Diameter | 3.55 | |
| Length | 6.35 | ||
| Predicate device | |||
| K052957 | Image: dental implant | Diameter | 3.18 / 3.37 / 4.12 |
| Length | 6.36 / 6.88 / 8.92 | ||
| K112045 | Image: dental implant | Diameter | 3.10 / 3.50 |
| Length | 4.70 / 5.70 | ||
| K153268 | Image: dental implant | Diameter | 3.50 / 4.30 |
| Length | 5.40 / 5.75 | ||
| K141457 | Image: dental implant | Diameter | 3.55 |
| Length | 6.35 |
1) Similarities
The subject Cover Screws have the same characteristics for the followings compared to the primary predicate device.
- Indication for use, Material, Dimension
The subject Cover Screws have the same dimensions cleared under K052957, K112045, K153268 and K141457.
2) Differences
The subject Cover Screws have the different characteristic for the following compared to the primary predicate device.
- Sterilization Method
10
3) Discussion
The purpose of this submission is to change the sterilization method of Cover Screws previously cleared under K052957, K112045, K153268 and K141457. These Cover Screws which have been provided non-sterile will be sterilized by gamma radiation. In terms of sterilization method there is difference between the subject device and primary predicate device. However the sterilization method of subject device was validated according to ISO 111137-1 and ISO 11137-2, demonstrating a sterility assurance level (SAL) of 10-6.
In conclusion, the subject device is substantially equivalent to the predicate device because it is verified that the difference does not affect substantial equivalence.
8. Conclusion
Based on the information provided, the subject device is substantially equivalent to the predicate devices.