(175 days)
No
The summary describes a physical dental implant system and its components, materials, and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an endosseous dental implant system intended for prosthetic restoration to restore chewing function. It replaces missing teeth but does not treat or cure a disease or medical condition.
No
The device is described as an "endosseous dental implant" and "aid in prosthetic restoration" to restore chewing function. Its function is to provide a root for prosthetic attachment, not to diagnose a condition.
No
The device description explicitly states it is made of pure titanium and titanium alloy and describes physical components (abutments, healing cap) with a physical coating. This indicates a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an endosseous dental implant used for surgical placement in the jaw to support prosthetic appliances and restore chewing function. This is a surgical and restorative purpose, not a diagnostic one.
- Device Description: The description details the materials and components of a dental implant system, which are physical devices implanted into the body. IVDs are typically reagents, instruments, or systems used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples or provide diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on biocompatibility, fatigue testing, and sterilization, which are relevant to the safety and function of an implantable device, not a diagnostic test.
In summary, the s-Clean TiN Coating Abutments are a medical device used for surgical and restorative purposes within the body, not for performing in vitro diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The s-Clean TiN Coating Abutments are device made of pure titanium and titanium alloy intended for use as an aid in prosthetic restoration.
The system consists of s-Clean TiN Half Coating Angled Abutment, s-Clean TiN Half and partial Coating Couple Abutment, s-Clean TiN Half Coating Free Abutment, s-Clean TiN Half Coating FreeMill Abutment, s-Clean TiN Half Coating MOA Abutment, s-Clean TiN Partial Sub-Octa Abutment, s-Clean TiN Partial Coating Sole Abutment, s-Clean DOA Ball Abutment, s-Clean DOA Snap Abutment, and s-Clean Sole Abutment Healing Cap.
The dimension of each abutment ranges as below:
- s-Clean TiN Half Coating Angled Abutment: Ø4.5, 5.0, 5.5 and 6.5 mm (D) x 10.18, 10.46, . 11.04, 11.18, 11.46, 11.6, 13.04, 13.18, 13.46 and 13.6 mm (L) x 15° and 25°
- s-Clean TiN Half and Partial Coating Couple Abutment: Ø4.5, 4.8, 5.5 and 6.5 mm (D) x 0.8, 1.3, ● 1.8, 2.3, 3.3, 4.3 and 5.3mm (Cuff H)
- . s-Clean TiN Half Coating Free Abutment: Ø4.5. 5.5 and 6.5mm (D) x 15.36 and 15.5mm (L)
- s-Clean TiN Half Coating FreeMill Abutment: Ø4.0, 4.5, 5.5, 6.5mm (D) and 7.5mm (D) x 1.3, ● 1.8, 2.8, 3.8 mm (Cuff H)
- . s-Clean TiN Half Coating MOA Abutment: Ø4.5 and 5.5mm(D) x 12.64, 14.14, 14.64, 15.14 and 16.14mm(L)
- s-Clean TiN Partial Sub-Octa Abutment: Ø 4.8 mm (D) x 0.8, 1.3, 2.3, 3.3, 4.3 and 5.3 mm (Cuff ● H)
- . s-Clean TiN Partial Coating Sole Abutment: Ø4.5. 5.5. 6.0 and 6.5 mm (D) x 0.8. 1.3. 1.8. 2.3. 4.3, and 5.3mm (Cuff H)
- s-Clean DOA Ball Abutment: Ø3.5 mm (D) x 0.6, 1.6, 2.6, 4.6, 5.6 (Cuff H) ●
- s-Clean DOA Snap Abutment: Ø3.5 mm (D) x 3.35 (Cuff H) ●
- s-Clean Sole Abutment Healing Cap: Ø4.6, 5.1, 5.9, 6.3, 6.8 and 6.9mm (D) x 6, 7, 7.5 and 9 mm (L)
The surface of the abutments is partially or half TiN Coated by using PVD (Physical Vapor Deposition).
The subject device is compatible with:
Dentis Dental Implant System (K171027)
Dentis Dental Implant System (K082843)
Haptite Coating Implant System (K111364)
Dentis Dental Implant System (K150344)
oneq-sl s-clean implant system (K153639)
s-clean tapered ii rbm implant system (K160213)
The subject device is provided non-sterile and should be sterilized before use (End user sterilization).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower jaw arches
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 Test Data:
Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ISO 10993-10:2010 and ISO 10993-11:2006.
Fatigue Testing according to ISO 14801:2007.
Below tests were performed for predicate devices and leveraged for the subject device:
End User Steam Sterilization Test according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ST79 referenced in K161244.
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.
Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K153521.
The end user sterilization test was performed for predicate device, K161244 and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging is the exactly the same as the predicate, K161244.
Fatigue evaluation was performed on the subject device under worst case scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Summary of clinical testing: No clinical testing was performed for this submission.
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.
K082843, K111364, K161244, K153521, K142211, K171027
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.
November 29, 2017
Dentis Co., Ltd. % April Lee Consultant Withus Group Inc. 2531 Pepperdale Drive Rowland Heights, California 91748
Re: K171694
Trade/Device Name: s-Clean TiN Coating Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 25, 2017 Received: October 31, 2017
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. 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.
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
1
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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) K171694
Device Name s-Clean TiN Coating Abutments
Indications for Use (Describe)
The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
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
Dentis Co., Ltd. Sun Chul Shin 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 South Korea Phone: +82-53-583-2804 Fax: +82-53-583-2806
Device Information
Trade Name: s-Clean TiN Coating Abutments Common Name: Dental Abutment Classification Name: Endosseous Dental Abutment Product Code: NHA Panel: Dental Regulation Number: 872.3630 Device Class: Class II Date Prepared: 11/20/2017
Official Correspondent
Withus Group Inc. April Lee 2531 Pepperdale Drive Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 909-274-9971 Fax: 909-460-8122
Description
The s-Clean TiN Coating Abutments are device made of pure titanium and titanium alloy intended for use as an aid in prosthetic restoration.
The system consists of s-Clean TiN Half Coating Angled Abutment, s-Clean TiN Half and partial Coating Couple Abutment, s-Clean TiN Half Coating Free Abutment, s-Clean TiN Half Coating FreeMill Abutment, s-Clean TiN Half Coating MOA Abutment, s-Clean TiN Partial Sub-Octa Abutment, s-Clean TiN Partial Coating Sole Abutment, s-Clean DOA Ball Abutment, s-Clean DOA Snap Abutment, and s-Clean Sole Abutment Healing Cap.
The dimension of each abutment ranges as below:
- s-Clean TiN Half Coating Angled Abutment: Ø4.5, 5.0, 5.5 and 6.5 mm (D) x 10.18, 10.46, . 11.04, 11.18, 11.46, 11.6, 13.04, 13.18, 13.46 and 13.6 mm (L) x 15° and 25°
- s-Clean TiN Half and Partial Coating Couple Abutment: Ø4.5, 4.8, 5.5 and 6.5 mm (D) x 0.8, 1.3, ● 1.8, 2.3, 3.3, 4.3 and 5.3mm (Cuff H)
- . s-Clean TiN Half Coating Free Abutment: Ø4.5. 5.5 and 6.5mm (D) x 15.36 and 15.5mm (L)
- s-Clean TiN Half Coating FreeMill Abutment: Ø4.0, 4.5, 5.5, 6.5mm (D) and 7.5mm (D) x 1.3, ● 1.8, 2.8, 3.8 mm (Cuff H)
- . s-Clean TiN Half Coating MOA Abutment: Ø4.5 and 5.5mm(D) x 12.64, 14.14, 14.64, 15.14 and 16.14mm(L)
- s-Clean TiN Partial Sub-Octa Abutment: Ø 4.8 mm (D) x 0.8, 1.3, 2.3, 3.3, 4.3 and 5.3 mm (Cuff ● H)
- . s-Clean TiN Partial Coating Sole Abutment: Ø4.5. 5.5. 6.0 and 6.5 mm (D) x 0.8. 1.3. 1.8. 2.3. 4.3, and 5.3mm (Cuff H)
4
- s-Clean DOA Ball Abutment: Ø3.5 mm (D) x 0.6, 1.6, 2.6, 4.6, 5.6 (Cuff H) ●
- s-Clean DOA Snap Abutment: Ø3.5 mm (D) x 3.35 (Cuff H) ●
- s-Clean Sole Abutment Healing Cap: Ø4.6, 5.1, 5.9, 6.3, 6.8 and 6.9mm (D) x 6, 7, 7.5 and 9 mm (L)
The surface of the abutments is partially or half TiN Coated by using PVD (Physical Vapor Deposition).
The subject device is compatible with:
| Compatible Implant names | Implant Models | Sizes |
|---|---|---|
| Dentis Dental Implant System | ||
| (K171027) | s-Clean Tapered Fixture | |
| s-Clean SAVE Fixture | Diameters: Ø3.7, 4.3, 4.8, 5.5, 6.0 | |
| Length: 7, 8, 10, 12, 14mm | ||
| Dentis Dental Implant System | ||
| (K082843) | s-Clean SAVE Fixture | Diameters: Ø6.5, 7.0 |
| Lengths:7, 8, 10, 12mm | ||
| Haptite Coating Implant System | ||
| (K111364) | HAPTITE s-Clean Tapered Fixture | |
| HAPTITE s-Clean Straight Fixture | ||
| HAPTITE s-Clean SAVE Fixture | Diameters: Ø3.7, 4.1, 4.3, 4.8, 5.5, | |
| 6.0, 6.5, 7.0 | ||
| Lengths:7, 8, 10, 12, 14mm | ||
| Dentis Dental Implant System | ||
| (K150344) | s-Clean Tapered Fixture | Diameters: Ø3.7, 4.1, 4.8 |
| Lengths:7, 8, 10, 12, 14mm | ||
| oneq-sl s-clean implant system | ||
| (K153639) | OneQ-SL s-Clean Fixture | Diameters: Ø 3.7, 3.9, 4.2, 5.2, 6.0, |
| 7.0, 8.0 | ||
| Lengths:7, 8, 10, 12, 14mm | ||
| s-clean tapered ii rbm implant | ||
| system (K160213) | s-Clean Tapered II RBM Fixture | Diameters: Ø3.7, 4.1, 4.3, 4.8 |
| Lengths:7, 8, 9, 10, 12, 14mm |
The subject device is provided non-sterile and should be sterilized before use (End user sterilization).
Indication for Use
The s-Clean TiN Coating Abutments is an endosseous dental implant that is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple-units prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading when good primary stability has been achieved and with appropriate occlusal loading.
5
Predicate Device & Comparison
The subject device is substantially equivalent to the following predicate devices:
Primary Predicate
- K171027, Dentis Dental Implant System by Dentis Co., Ltd.
Reference Predicates
- K082843, Dentis Dental Implant System by Dentis Co., Ltd. ●
- K111364, Haptite Coating Implant System by Dentis Co., Ltd. .
- K161244, S-Clean Oneq-sl Narrow Implant System by Dentis Co., Ltd. .
- K153521, IH Prosthetic System by Sewon Medix Inc. .
- K142211, OT Equator by Rhein'83 Srl. .
| | Subject device | Primary Predicate | Reference Predicate | Reference Predicate | Reference Predicate | | stage surgical process
with an option for
transmucosal healing or
they can be placed in a
single stage surgical
process for immediate
loading when good
primary stability has been
achieved and with
appropriate occlusal
loading. | surgical process with an
option for transmucosal
healing or they can be
placed in a single stage
surgical process for
immediate loading when
good primary stability has
been achieved and with
appropriate occlusal
loading. | two stage surgical
procedures and not for
immediate load. Also, this
system is intended to be
used in the molar region. | is dedicated for one and
two stage surgical
procedures and not
dedicated for immediate
loading. This system is
intended for delayed
loading. | bridgework. IH Implant
System is for single and
two stage surgical
procedures. It is intended
for delayed loading. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | NA | K171027 | K082843 | K111364 | K153521 | Product Name | s-Clean TiN Half
Coating Angled
Abutment | - | Submerged Angled
Abutment | - | Angled Abutment |
| Product Name | s-Clean TiN Coating
Abutments | Dentis Dental Implant
System | Dentis Dental Implant
System | Haptite Coating Implant
System | IH Prosthetic System | Dimension | Ø4.5, 5.0, 5.5 and 6.5
mm (D) x
10.18, 10.6, 10.46,
11.04, 11.18, 11.46,
11.6, 13.04, 13.18,
13.46 and 13.6 mm (L)
x 15° and 25° | - | Ø4.5, 5.0, 5.5 and 6.5
mm (D) x
9, 10.5, 12 mm (L) | - | Ø 4.5/5.0/5.5 /6.0
X
9.5, 10, 10.5,
11, 11.5, 12 (L) |
| Manufacturer | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. | Dentis Co., Ltd. | Sewonmedix Inc. | Material | Ti-6Al-4V ELI(Grade
5) | - | Ti-6Al-4V ELI(Grade
5) | - | Ti-6Al-4V ELI(Grade
5) |
| Indications for Use | The s-Clean TiN Coating
Abutments is an
endosseous dental implant
that is indicated for
surgical placement in the
upper and lower jaw
arches, to provide a root
form means for single or
multiple-units prosthetic
appliance attachment to
restore a patient's
chewing function.
Implants can be placed
with a conventional two | The Dentis Dental Implant
System is an endosseous
dental implant that is
indicated for surgical
placement in the upper
and lower jaw arches, to
provide a root form means
for single or multiple-
units prosthetic appliance
attachment to restore a
patient's chewing
function. Implants can be
placed with a
conventional two stage | The Dentis Dental Implant
System is indicated for
use in partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple-unit
restorations including;
cemented retained, screw
retained, or overdenture
restorations, and terminal
or intermediate abutment
support for fixed
bridgework. This system
is dedicated for one and | The HAPTITE Coating
Implant System is
indicated for use in
partially or fully
edentulous mandibles and
maxillae, in support of
single or multiple-unit
restorations including;
cemented retained, screw
retained, or overdenture
restorations, and terminal
or intermediate abutment
support for fixed
bridgework. This system | IH Implant System is
device made of titanium
and titanium alloy
indicated for in partially
or fully edentulous
mandibles and maxillae,
in support of single or
multiple-unit restorations
including; cemented
retained or screw retained
restorations and terminal
or interminal abutment
support for fixed | Coating | TiN coating | - | NA | - | TiN coating |
| Angulation | 15°/25° | - | 15°/25° | - | 15°/25° | | | | | | |
| Product Name | s-Clean TiN Half
Coating Couple
Abutment | Couple Abutment | - | - | Cement Abutment | | | | | | |
6
7
| Dimension | Ø4.5, 4.8, 5.5 and 6.5 mm (D) x
0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and 5.3mm (Cuff H) | Ø4.0, 4.5, 4.8, 5.5, 6.0 and 6.5 mm (D) x
0.8, 1.3, 1.8, 2.3, 3.3, 4.3 and 5.3mm (Cuff H) | - | Ø4.5/5.0/5.5/6.0/6.5 X
1.0/1.5/2.0/2.5
/3.0/3.5/4.0/4.5/5.0
(Cuff H) | |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------|---------------------------|
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - | Ti-6Al-4V ELI(Grade 5) | |
| Coating | TiN coating | NA | - | TiN coating | |
| Product Name | s-Clean TiN Half
Coating Free Abutment | Free Abutment | - | - | |
| Dimension | Ø4.5, 5.5 and 6.5mm
(D) x 15.36 and
15.5mm (L) | Ø4.5 and 5.5 and
6.5mm (D) x
15.36 and 15.5mm (L) | - | - | |
| Material | Pure Titanium (Grade 4) | Pure Titanium (Grade 4) | - | - | |
| Coating | TiN coating | NA | - | - | |
| Product Name | s-Clean TiN Half
Coating FreeMill
Abutment | - | - | FreeMilling Abutment | |
| Dimension | Ø4.0, 4.5, 5.5, 6.5mm
(D) and 7.5mm (D) x
1.3, 1.8, 2.8, 3.8 mm
(Cuff H) | - | - | Ø 4.5/5.0
/5.5/6.0/6.5mm (D) x
1.0/2.0 /3.0mm
(Cuff H) | |
| Material | Pure Titanium (Grade 4) | - | - | Pure Titanium
(Grade 4) | |
| Coating | TiN coating | - | - | TiN coating | |
| Product Name | s-Clean TiN Half
Coating MOA
Abutment | - | MOA Abutment | - | |
| Dimension | Ø4.5 and 5.5mm(D) x
12.64, 14.14, 14.64,
15.14 and 16.14mm(L) | - | Ø4.0 and 5.5mm(D) x
12.64, 14.14, 14.64,
15.14 and 16.14mm(L) | - | |
| Material | Ti-6Al-4V ELI(Grade
5) | - | Ti-6Al-4V ELI(Grade
5) | - | |
| Coating | TiN coating | - | - | - | |
| Product Name | s-Clean TiN Partial
Coating Sub-Octa
Abutment | Sub-Octa Abutment | - | - | |
| Dimension | Ø4.8 mm (D) x
0.8, 1.3, 2.3, 3.3, 4.3
and 5.3 mm (Cuff H) | Ø4.8mm (D) x
0.8, 1.3, 2.3, 3.3, 4.3
and 5.3 mm (Cuff H) | - | - | |
| Material | Ti-6Al-4V ELI(Grade
5) | Ti-6Al-4V ELI(Grade
5) | - | - | |
| Coating | TiN coating | - | - | - | |
| Product Name | s-Clean TiN Partial
Coating Sole Abutment | Sole Abutment | - | Solid Abutment | |
| Dimension | Ø4.5, 5.5, 6.0 and 6.5
mm (D) x 0.8, 1.3, 1.8, | Ø4.5, 5.5, 6.0 and 6.5
mm (D) x 0.8, 1.3, 1.8, | - | Ø4.0/4.5/5.0/5.5/
6.0/6.5/7.0
X 1.0/1.5/2.0/2.5/ | |
| | 2.3, 4.3, and 5.3mm
(Cuff H) | 2.3 4.3 and 5.3mm
(Cuff H) | | | 3.0/3.5/4.0/4.5/5.0 (L) |
| Material | Ti-6Al-4V ELI(Grade
5) | Ti-6Al-4V ELI(Grade
5) | | | Ti-6Al-4V ELI(Grade
5) |
| Coating | TiN coating | | | | TiN coating |
| Product Name | s-Clean DOA Ball
Abutment | O-Ring Abutment | | | |
| Dimension | Ø3.5 mm (D) x 1.0, 2.0.
3.0, 4.0, 5.0(Cuff H) | Ø3.5 mm (D) x 0.5, 2
and 4 mm (Cuff H) | | | |
| Material | Ti-6Al-4V ELI(Grade
న) | Ti-6Al-4V ELI(Grade
5) | | | |
| Coating | TiN coating | | | | |
| Product Name | Sole Healing Cap | | | Sole Healing Cap | |
| Dimension | Ø4.6, 5.1, 5.9, 6.3, 6.8
and 6.9mm (D) x 6, 7,
7.5 and 9 mm (L) | | | Ø4.9mm (D) x 4.0 mm
(L) | |
| Material | Acetal | | | Acetal | |
| Sterilization | Steam sterilization by
user | Steam sterilization by
user | Steam sterilization by
user | Steam sterilization by
user | |
| Product Code | NHA | NHA | NHA | NHA | |
| Brief Discussion | The subject device is similar to the predicate devices in shape, angulation, structure, dimension, and material. The
difference is TiN coated surface treatment of the abutments. | | | | |
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9
10
s-Clean DOA Snap Abutment
| Subject device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| 510(k) number | NA | K142211 | K171027 |
| Product Name | s-Clean TiN Coating Abutments | OT EQUATOR | Dentis Dental Implant System |
| Manufacturer | Dentis Co., Ltd. | Rhein'83 Srl | Dentis Co., Ltd. |
| Indications for Use | The s-Clean TiN Coating Abutments is an | ||
| endosseous dental implant that is indicated for | |||
| surgical placement in the upper and lower jaw | |||
| arches, to provide a root form means for single | |||
| or multiple-units prosthetic appliance | |||
| attachment to restore a patient's chewing | |||
| function. Implants can be placed with a | |||
| conventional two stage surgical process with an | |||
| option for transmucosal healing or they can be | |||
| placed in a single stage surgical process for | |||
| immediate loading when good primary stability | |||
| has been achieved and with appropriate | |||
| occlusal loading. | The OT Equator is designed as | ||
| an endosseous dental implant | |||
| retentive component used to | |||
| retain a complete or partial | |||
| denture. The OT Equator is | |||
| screwed into an endosseous | |||
| implant in the mandible or | |||
| maxilla. | |||
| The OT Equator abutments are | |||
| indicated for use with the | |||
| implant systems listed in | |||
| Attachment B. | The Dentis Implant System is an endosseous dental | ||
| implant that is indicated to use for surgical placement | |||
| in the upper and lower jaw arches, to provide a root | |||
| form means for single or multiple units' prosthetic | |||
| appliance attachment to restore a patient's chewing | |||
| function. Implants can be placed with a conventional | |||
| two stage surgical process with an option for | |||
| transmucosal healing or they can be placed in a single | |||
| stage surgical process for immediate loading. | |||
| Immediate loading is restricted to the anterior | |||
| mandible, based on four splinted interforminal placed | |||
| implants, and not indicated for single, unsplinted | |||
| implants. Patients must be subject for dental treatment | |||
| with endosseous implants. | |||
| Product Name | s-Clean DOA Snap Abutment | OT Equator Abutment | - |
| Dimension | Ø3.5 mm (D) x 3.35 (Cuff H) | Ø2.5 mm (D) x 1-7 mm(Cuff | |
| H) | - | ||
| Material | Ti-6Al-4V ELI(Grade 5) | Ti-6Al-4V ELI(Grade 5) | - |
| Coating | TiN coating | TiN coating | - |
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Non-Clinical Test Data
The subject device was tested to evaluate its substantial equivalence according to the following standards.
- Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-3:2014, ISO 10993-5:2009, ● ISO 10993-10:2010 and ISO 10993-11:2006.
- Fatigue Testing according to ISO 14801:2007 ●
Below tests were performed for predicate devices and leveraged for the subject device:
- End User Steam Sterilization Test according to ISO 17665-1:2006, -2:2009 and ANSI/AAMI ● ST79 referenced in K161244
The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device.
Biocompatibility Test was conducted for the subject devices and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K153521.
The end user sterilization test was performed for predicate device. K161244 and leveraged for the subject device because the product category, material, manufacturing process, facility, and packaging is the exactly the same as the predicate, K161244.
Fatigue evaluation was performed on the subject device under worst case scenario in accordance with ISO 14801 and "Guidance for Industry and Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
The non-clinical testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Summary of clinical testing
No clinical testing was performed for this submission.
Substantial Equivalence Discussion
Similarities:
The subject device has identical, machining, manufacturing process, angulation and indication for use and similar design, dimension and technological characteristics as the predicate devices.
The subject device has been supposed to performance and product validations prior to release. Testing including biocompatibility tests and fatigue test has been performed to ensure the devices comply with the applicable International and US FDA Guidance.
Differences:
The differences between the subject device and predicate devices are detailed shape and dimension of each abutment and area of TiN Coated surface treatment.
Any differences between the subject device and predicate devices do not raise new types of substantially equivalent issues.
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Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Dentis Co., Ltd. Concludes that the s-Clean TiN Coating Abutments is substantially equivalent to the predicate devices as described herein.