(586 days)
No
The document describes a physical dental implant system and does not mention any software, algorithms, or data processing related to AI/ML.
No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device is a dental implant system used to replace missing teeth, which is a restorative rather than a therapeutic function.
No
The device description and intended use indicate that the LOTA SLA Dental Implant System and LOTA HA Dental Implant System are dental implants used for surgical placement to support restorations for missing teeth. There is no mention of diagnosing conditions or diseases.
No
The device description clearly states it is a dental implant system made of Titanium 6AL 4V ELI alloy, which is a physical hardware component. The performance studies also focus on hardware-related testing like sterilization, shelf life, and material properties.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device for surgical implantation in the jawbone to support dental restorations. This is a surgical device, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the material, placement, and use with abutments, all related to a surgically implanted dental device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD.
Therefore, this device falls under the category of a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are 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. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. All diameters are available with all lengths.
| Implant Diameter | 3.8mm, 4.3mm, 4.8mm, 5.3mm, 6.3mm, 7.3mm |
|---|---|
| Implant Length | 8.0mm, 9.0mm, 10.0mm, 11.0mm, 12.0mm, 13.0mm, 14.0mm |
The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.
- Shouldered Abutment
- Shouldered Hex Abutment
- Shouldered Removal Abutment
The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
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)
Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification and based on the analysis, the following activities/tests were performed.
- Identifying reference devices for the modifications in fixture thread design, the fixture size, and abutment design to make sure the subject device is not introducing new design or size range which will raise a concern.
- For the modification in surface treatment, identifying a predicate device which is made by our company having the same material/surface treatment and going through the same manufacturing processes.
- Sterilization validation test in accordance with ISO 11137-1 and 11137-2, and shelf life validation tests in accordance with ASTM F1980-7, ASTM F88, ISO 11607, and ISO 11737-2.
- Endotoxin testing for lot release was evaluated in accordance with USP 39 the endotoxin limit which is 0.5 EU/mL.
- Scanning Electron Microscopy (SEM) to validate there is no residual remaining on the implants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Endotoxin limit which is 0.5 EU/mL.
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.
K092035, K170044, K150060, K161923
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
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that 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, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
KJ Meditech Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620
Re: K202046
Trade/Device Name: LOTA SLA Dental Implant System and LOTA HA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 9, 2022 Received: February 18, 2022
Dear Priscilla Chung:
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)
Device Name
LOTA SLA Dental Implant System and LOTA HA Dental Implant System
Indications for Use (Describe)
The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are 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. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed 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 (K202046)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 2/28/2022
1. Submitter
KJ Meditech Co., Ltd. 959-21 Daechon-dong, Buk-gu, Gwang-ju, Republic of Korea
Tel: +82-62-972 -5476
Contract Person: Hyuckki Moon / President
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- Trade Name: LOTA SLA Dental Implant System ● LOTA HA Dental Implant System
- Common Name: Dental implant system
- Classification Name: Endosseous dental implant ●
- . Product Code: DZE, NHA
- Classification regulation: 21 CFR 872.3640
4. Predicate Device
- Primary Predicate: ●
- KJ Submerged System by KJ Meditech Co., Ltd. (K103810) -
- . Reference Devices:
4
- -Bicon Implants with a 2.5mm Internal Connection by BICON, LLC (K092035)
- -Inclusive® Titanium Abutments compatible with: MegaGen AnyRidge® Implant System by Megagen Implant Co., Ltd. (K170044)
- J2a Dental Implant System, J2c Dental Implant System by KJ Meditech Co., Ltd. -(K150060)
- J2A SLA Dental Implant System by KJ Meditech Co., Ltd. (K161923) -
5. Device Description
The LOTA SLA Dental Implant system and LOTA HA Dental Implant System are dental implant systems made of Titanium 6AL 4V ELI alloy, which confirms to ASTM F136, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. All diameters are available with all lengths.
| Implant Diameter | 3.8mm, 4.3mm, 4.8mm, 5.3mm, 6.3mm, 7.3mm |
|---|---|
| Implant Length | 8.0mm, 9.0mm, 10.0mm, 11.0mm, 12.0mm, 13.0mm, 14.0mm |
The implants are used with the following abutments. The Shouldered Abutments and the Shouldered Hex Abutments have internal connection structure, and they adopt locking taper connection. They restore fixed crown and bridge restorations. The Shouldered Removal Abutment uses screw and locking taper connection to be connected with the fixture. It has the same intended use as the other abutments. All the abutments are not intended for angulation.
- I Shouldered Abutment
- 트 Shouldered Hex Abutment
- 트 Shouldered Removal Abutment
The systems are similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics.
6. Indication for Use
The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are 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. The LOTA SLA Dental Implant System and LOTA HA Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
5
7. Basis for Substantial Equivalence
The subject device and the predicate device (KJ Submerged System, K103810) have the same indications and fundamental scientific technology. The subject and predicate devices employ the same materials and have very similar in design. The fixture thread design, the fixture size, and abutment design have changed, and we have identified a reference device which are similar in design and size. The Bicon Implants (K092035) has similar thread design, and the J2a Dental Implant System, J2c Dental Implant System have similar neck micro-threading design. We identified MegaGen AnyRidge® Implant System (K170044) as a reference device which encompasses the size range of the subject device.
Another difference is that the subject fixtures have SLA treatment. This difference poses potential risks in biocompatibility, sterilization/shelf-life validation, and residual remining on the fixtures. To mitigate these risks, we identified a predicate device made by our company(K161923) which go through the same manufacturing processes and have the same material/surface treatment. Also, we performed sterilization/shelf-life validation tests, and SEM analysis to validate that the modification would not raise an issue to support substantial equivalence.
| Item | Subject
Device | Predicate
Device | Reference
Device | Reference Device | Reference
Device | Reference Device |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K)
Number | K202046 | K103810 | K092035 | K170044 | K150060 | K161923 |
| Device Name | LOTA SLA/
HA Dental
Implant | KJ
Submerged
System | Bicon
Implants
with a
2.5mm
Internal
Connection | Inclusive® Titanium
Abutments
compatible with:
MegaGen
AnyRidge® Implant
System | J2a Dental
Implant
System, J2c
Dental
Implant
System | J2A SLA Dental
Implant |
| Manufacturer | KJ Meditech
Co., Ltd. | KJ Meditech
Co., Ltd. | BICON,
LLC | Megagen Implant
Co.,Ltd. | KJ Meditech
Co., Ltd. | KJ Meditech Co.,
Ltd. |
| Indications
for Use | The LOTA
SLADental
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. | The KJ
Submerged
System is
indicated for
use in
partially or
fully
edentulous
mandibles
and
maxillae, in
support of
single or
multiple-
unit
restorations
including;
cemented | The Bicon
implant is
designed for
use in
edentulous
sites in the
mandible or
maxilla for
support of a
complete
denture
prosthesis, a
final or
intermediate
abutment for
fixed
bridgework
or for partial | Inclusive®
Titanium
Abutments are
premanufactured
prosthetic
components
connected to
endosseous
dental implants
in the
edentulous or
partially
edentulous
maxilla or
mandible to
provide support
for cement-
retained or | The J2C
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. | The J2A SLA
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 |
| | screw
retained, or
overdenture
restorations,
and terminal
or
intermediate
abutment
support for
fixed
bridgework.
The LOTA
SLA Dental
Implant is for
single and
two stage
surgical
procedures.
The system is
intended for
delayed
loading. | retained,
screw
retained, or
overdenture
restorations,
and terminal
or
intermediate
abutment
support for
fixed
bridgework.
The KJ
Submerged
System is
for single
and two
stage
surgical
procedures.
The system
is intended
for delayed
loading. | dentures, or
as a single
tooth
replacement. | screw-retained
prosthetic
restorations. | screw
retained, or
overdenture
restorations,
and terminal
or
intermediate
abutment
support for
fixed
bridgework.
The J2C
Dental
Implant
System is for
single and
two stage
surgical
procedures.
The system is
intended for
delayed
loading. | intermediate
abutment support
for fixed
bridgework. The
J2A SLA Dental
Implant is for
single and two
stage surgical
procedures. The
system is intended
for delayed
loading. |
| Design | • Implant
Type:
Bone Level
Implant
• Connection
Type:
Internal
Locking
Taper
• Neck
Design:
Straight
walled
neck
• Body
Design:
Tapered
design | • Implant
Type:
Bone
Level
Implant
• Connection
: Internal
Locking
Taper
• Neck
Design:
Straight
walled
neck
• Body
Design:
Tapered
design | • Implant
Type:
Bone
Level
Implant
• Connection:
Internal
Locking
Taper
• Neck
Design:
Straight
walled
neck
• Body
Design:
Tapered
design | All digitally
designed
abutments for
use with
Inclusive
Abutments for
CAD/CAM are
intended to be
sent to a
Prismatik
Dental craft
validated milling
center for
manufacture.
Compatible
Implant System:
MegaGen
AnyRidge®
Implant System
Inclusive Titanium
Abutments
compatible with
MegaGen AnyRidge
Implant System | • Implant
Type: Bone
Level
Implant
• Connection
Type:
Internal
Hexagon
• Neck
Design:
Straight
walled
neck with
micro-
thread
• Body
Design:
Tapered
design | • Implant Type:
Bone Level
Implant
• Connection
Type: Internal
Hexagon
• Neck Design:
Straight walled
neck
• Body Design:
Tapered design |
| Endosseous
Implant
Material | Ti 6Al 4V
ELI, ASTM
F136 | Ti 6Al 4V
ELI, ASTM
F136 | Ti 6Al 4V
ELI,
ASTM F136 | Ti 6Al 4V ELI,
ASTM F136 | Ti 6Al 4V
ELI, ASTM
F136 | Ti 6Al 4V ELI,
ASTM F136 |
| Surface
Treatment | SLA
Treatment | RBM
Treatment
HA Coating | HA Coating | S-L-A with Nano
Ca2+ incorporated | RBM
Treatment | SLA Treatment |
LOTA SLA/HA Fixture
510(k) summary
3 / 6 page
6
7
| Sterilization
| Method | Gamma | Gamma | Gamma | Gamma | Gamma | Gamma |
|---|---|---|---|---|---|---|
| Implant | ||||||
| Diameters | 3.8mm, | |||||
| 4.3mm, | ||||||
| 4.8mm, | ||||||
| 5.3mm, | ||||||
| 6.3mm, | ||||||
| 7.3mm | 3.5mm, | |||||
| 4.0mm, | ||||||
| 4.5mm, | ||||||
| 5.0mm, | ||||||
| 5.5mm, 6.0 mm | 4.0 mm, | |||||
| 4.5mm | 3.5mm, 4.0mm, | |||||
| 4.4mm, 4.9mm | ||||||
| 5.4mm, 5.9mm | ||||||
| 6.4mm, 6.9mm | ||||||
| 7.4mm, 7.9mm | ||||||
| 8.4mm | 3.75mm, | |||||
| 4.00mm, | ||||||
| 4.30mm, | ||||||
| 4.50mm, | ||||||
| 5.00mm, | ||||||
| 5.50mm, | ||||||
| 6.00mm | 3.75mm, 4.0mm, | |||||
| 4.3mm, 4.5mm, | ||||||
| 5.0 mm, 5.5mm, | ||||||
| 6.0mm | ||||||
| Implant | ||||||
| Lengths | 8.0mm, | |||||
| 9.0mm, | ||||||
| 10.0mm, | ||||||
| 11.0mm, | ||||||
| 12.0mm, | ||||||
| 13.0mm, | ||||||
| 14.0mm | 8.10mm, | |||||
| 8.30mm, | ||||||
| 8.64mm, | ||||||
| 8.91mm, | ||||||
| 9.00mm, | ||||||
| 9.69mm, | ||||||
| 10.0mm, | ||||||
| 11.0mm, | ||||||
| 12.0mm, | ||||||
| 14.0mm | 5.0mm, | |||||
| 6.0 mm, | ||||||
| 8.0 mm, | ||||||
| 11.0mm | 7.0mm, 8.5mm | |||||
| 10.0mm, 11.5mm | ||||||
| 13.0mm, 15.0mm | 7mm, 8.5mm, | |||||
| 10.0mm, | ||||||
| 11.5mm, | ||||||
| 13.0mm, | ||||||
| 15mm | 7mm – 15.0 mm | |||||
| Cover Screw | N/A | N/A | N/A | N/A | Ti 6Al 4V | |
| ELI, ASTM | ||||||
| F136 | Ti 6Al 4V ELI, | |||||
| ASTM F136 |
LOTA Abutment
LOTA Shouldered Abutments
| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(K) | ||
| Number | K202046 | K103810 |
| Device Name | LOTA SLA Dental Implant | KJ Submerged System |
| Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. |
| One Piece | ||
| Abutment | ■ Ti 6Al 4V ELI, ASTM F136 | |
| ■ Well : Ø2.0~ Ø3.0 | ||
| ■ Diameter: Ø4.0mm ~ Ø6.5mm | ||
| ■ Height:6.85mm~11.35mm | ||
| Post Length: 2mm~4mm | ■ Ti6Al4V ELI, ASTM F136 | |
| ■ Well: Ø 2.0~ Ø 3.0 | ||
| ■ Diameter: Ø3.5mm~ Ø6.0mm | ||
| ■ Height:10.7mm~15mm | ||
| ■ Post Length: 4mm~6mm |
LOTA Shouldered Removal Abutments
| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(K) | ||
| Number | K202046 | K161923 |
| Device | ||
| Name | LOTA SLA Dental Implant | J2A SLA Dental Implant System |
| Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. |
8
| Two Piece
Abutment | • Ti 6Al 4V ELI, ASTM F136
• Well: Ø2.5Ø3.011.35mm
• Diameter: Ø5.0mm ~ Ø6.5mm
• Height: 6.85mm
• Post Length: 2mm4mm | • Ti 6Al 4V ELI, ASTM F136Ø3.33
• TiN Coating
• Well: Ø2.78
• Diameter: Ø4Ø75mm
• Cuff: 1mm
• Height: 4.0mm~7.0mm |
| ----------------------- | -------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------- |
|---|
8. Non-Clinical Testing
Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification and based on the analysis, the following activities/tests were performed.
- " Identifying reference devices for the modifications in fixture thread design, the fixture size, and abutment design to make sure the subject device is not introducing new design or size range which will raise a concern.
- For the modification in surface treatment, identifying a predicate device which is made by our company having the same material/surface treatment and going through the same manufacturing processes.
- . Sterilization validation test in accordance with ISO 11137-1 and 11137-2, and shelf life validation tests in accordance with ASTM F1980-7, ASTM F88, ISO 11607, and ISO 11737-2.
- Endotoxin testing for lot release was evaluated in accordance with USP 39 the endotoxin limit which is 0.5 EU/mL.
- Scanning Electron Microscopy (SEM) to validate there is no residual remaining on the implants.
9. Conclusion
Based on the similarities and the test results of the validation activities, we conclude that the LOTA SLA Dental Implant System and LOTA HA Dental Implant System are substantially equivalent to the predicate device.