IR SLA Type Implant System
Device Facts
| Record ID | K222144 |
|---|---|
| Device Name | IR SLA Type Implant System |
| Applicant | Biotem Co., Ltd. |
| Product Code | DZE · Dental |
| Decision Date | Jun 14, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
IR SLA Type 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. IR SLA Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR SLA Type Implant System is intended only for straight placement with no correction of angulation.
Device Story
Endosseous dental implant system; surgically placed in maxilla or mandible bone; replaces missing teeth. System comprises CP Ti Gr 4 titanium fixtures and various abutments. Fixtures feature SLA (sandblasted, large-grit, acid-etched) surface treatment to enhance bone-implant contact and cell activity. Used in one-stage surgical procedures; intended for delayed loading. Operated by dental professionals in clinical settings. Output is a stable foundation for dental restorations. Benefits include shortened treatment periods and improved patient satisfaction via enhanced osseointegration.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included sterilization validation (ISO 11137, ISO 17665), surface characterization (chemical/SEM analysis), biocompatibility (cytotoxicity ISO 10993-5, sensitization ISO 10993-10), endotoxin testing (USP <85>), and shelf-life validation (ISO 11607).
Technological Characteristics
Material: CP Ti Gr 4 (ASTM F67). Surface: SLA (sandblasted with <50μm HA particles, acid-etched). Design: Internal Octa Tapered. Sterilization: Gamma (fixtures), Steam (abutments). Dimensions: Diameters 3.5-5.5mm, Lengths 7.5-15.0mm.
Indications for Use
Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented or overdenture restorations and fixed bridgework support. Contraindicated for immediate loading; intended for delayed loading only. Restricted to straight placement.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Biotem IR Type Implant System (K171185)
Reference Devices
- AR N SLA Type Implant System (K190641)
Submission Summary (Full Text)
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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 seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Biotem Co., Ltd. % Joyce Kwon CEO Provision Consulting Group, Inc. 100 N Barranca St. Suite 700 West Covina, California 91791
Re: K222144
Trade/Device Name: IR SLA Type Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 15, 2023 Received: May 16, 2023
Dear Joyce Kwon:
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.
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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 mediation-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 -S
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
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# Indications for Use
510(k) Number (if known) K222144
Device Name IR SLA Type Implant System
#### Indications for Use (Describe)
IR SLA Type 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. IR SLA Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR SLA Type Implant System is intended only for straight placement with no correction of angulation.
Type of Use (Select one or both, as applicable)
| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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Image /page/3/Picture/0 description: The image contains the logo for Provision Consulting Group. The logo features a stylized bird in a teal color, with its wings spread. To the right of the bird is the text "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font below it. The overall design is clean and professional.
# 510(k) Summary
# 510(k) Submitter
Hong Koo Yeo Biotem Co., Ltd. 57, Sasang-ro, 401 beon-gil, Sasang-gu, Busan 46925 Republic of Korea +82-51-908-8257 info@provisionfda.com
#### Official Correspondent / Contact Person
Joyce Kwon, CEO/Principal Consultant Provision Consulting Group, Inc. 100 N. Barranca St. Suite 700 West Covina, CA 91791 +1-909-493-3276 joyce@provisionfda.com
# Date Prepared
June 14,2023
#### Device Information
- Trade Name: IR SLA Type Implant System ●
- Model Name: IR SLA Dental Implant
- . Common Name: Endosseous dental implant
- Classification Name: Implant, Endosseous, Root-Form ●
- Regulation Number: 21 CFR 872.3640 ●
- . Device Class: Class II
- Product Code: DZE, NHA ●
#### Predicate Devices
- Biotem IR Type Implant System (K171185) ● Endosseous dental implant
The predicates have not been subject to a design-related recall.
#### Reference Device
- · AR N SLA Type Implant System (K190641)
# Prior Submission Information
None
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Image /page/4/Picture/0 description: The image shows the logo for Provision Consulting Group. The logo features a stylized green bird on the left side. To the right of the bird are the words "PROVISION" in a larger, bold font, with the words "CONSULTING GROUP" underneath in a smaller font.
# Indication for Use
IR SLA Type 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, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. IR SLA Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR SLA Type Implant System is intended only for straight placement with no correction of angulation.
# Device Description
The IR SLA Type Implant System is a dental implant system made of CP Ti Gr 4, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The system has been treated with S.L.A.
| Endosseous Diameter | Endosseous Length (mm) |
|---------------------|----------------------------------|
| Ø 3.5 | 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 4.1 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 4.8 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
| Ø 5.5 | 7.5, 8.5, 10.0, 11.5, 13.0, 15.0 |
#### Substantial Equivalent Comparison Chart with Predicate Device and Reference Device
| | Subject Device | Primary Predicate Device | Reference Device |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | IR SLA Type Implant<br>System | IR Type Implant System | AR_N SLA Type<br>Implant System |
| 510(k) Number | K222144 | K171185 | K190641 |
| Manufacturer | Biotem Co., Ltd. | Biotem Co., Ltd. | Biotem Co., Ltd. |
| Regulation<br>Number | 21 CFR 872.3640 | 21 CFR 872.3640 | 21 CFR 872.3640 |
| Product code | DZE, NHA | DZE, NHA | DZE |
| Class | II | II | II |
| Indications for<br>Use | IR SLA Type Implant<br>System is indicated for<br>use in partially or fully<br>edentulous mandibles<br>and maxillae, in support<br>of single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. IR SLA<br>Type Implant System is<br>for one stage surgical<br>procedures. It is intended<br>for delayed loading. IR<br>SLA Type Implant<br>System is intended only<br>for straight placement<br>with no correction of<br>angulation. | IR Type Implant System<br>is indicated for use in<br>partially or fully<br>edentulous mandibles<br>and maxillae, in support<br>of single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework. IR Type<br>Implant System is for<br>one stage surgical<br>procedures. It is intended<br>for delayed loading. IR<br>Implant System is<br>intended only for straight<br>placement with no<br>correction of angulation. | AR_N SLA Type<br>Implant System is<br>indicated for use in<br>partially or fully<br>edentulous mandibles<br>and maxillae, in support<br>of single or multiple-unit<br>restorations including;<br>cemented retained, screw<br>retained, or overdenture<br>restorations, and terminal<br>or intermediate abutment<br>support for fixed<br>bridgework.<br>AR_N SLA Type<br>Implant System is for<br>two stage surgical<br>procedures. It is intended<br>for delayed loading. |
| Design | Internal Octa Tapered | Internal Octa Tapered | Internal Hex Submerged<br>Macro thread |
| Material | CP Ti Gr 4 ASTM F67 | CP Ti Gr 4 ASTM F67 | CP Ti Gr 4 ASTM F67 |
| Sterilization | Gamma sterilization | Gamma sterilization | Gamma sterilization |
| Fixture Diameter<br>(mm) | Ø 3.5, 4.1, 4.8, 5.5 | Ø 3.5, 4.1, 4.8, 5.5 | Ø 3.7, 4.2, 4.6, 5.1, 6.0 |
| Fixture Length<br>(mm) | 7.5, 8.5, 10.0, 11.5, 13.0,<br>15.0 | 7.5, 8.5, 10.0, 11.5, 13.0,<br>15.0 | 7.5, 8.5, 10.0, 11.5, 13.0,<br>15.0 |
| Abutment<br>Diameter (mm) | Ø 4.8, 6.0, 6.5 mm | Ø 4.8, 6.0, 6.5 mm | Ø 4.0 - 6.5 mm |
| Abutment Lengths<br>(mm) | 2.0, 3.0, 4.0, 5.5, 6.0, 7.0<br>mm | 2.0, 3.0, 4.0, 5.5, 6.0, 7.0<br>mm | 1.0 - 10.0 mm |
| Abutment Angled | 0° | 0° | 17°, 30° |
| Attachment | Various abutments and<br>components | Various abutments and<br>components | Various abutments and<br>components |
| Surface treatment | SLA | RBM | SLA |
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Image /page/5/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird in flight, with its wings spread and feathers detailed. To the right of the bird is the text "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font size underneath. The overall design is clean and professional.
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Image /page/6/Picture/0 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird in flight, with the word "PROVISION" in bold letters to the right of the bird. Below "PROVISION" is the text "CONSULTING GROUP" in a smaller font. The logo is simple and professional.
# Comparison of Abutments with Predicate Device
Material: Titanium Grade 4 / ASTM F67 Sterilization: Non-Sterile
# Closing Screw
| | Subject Device | Predicate Device (K171185) |
|--------------|----------------|----------------------------|
| Sizes | Product Codes | Product Code |
| Mini/Regular | CSI 4000 | CSI 4000 |
| Wide | CSI 4805W | CSI 4805W |
# Cover Screw
| | Subject Device | Predicate Device (K171185) |
|-----------|----------------|----------------------------|
| Sizes | Product Codes | Product Code |
| Mini | HAI 48601 | HAI 48601 |
| Regular | | |
| Wide Neck | HAI 60701 | HAI 60701 |
# Healing Abutment
| | Subject Device | | Predicate Device (K171185) | |
|--------------|----------------|---------|----------------------------|---------|
| Sizes | Product Codes | Heights | Product Code | Heights |
| | HAI 48602 | 2 | HAI 48602 | 2 |
| Mini/Regular | HAI 48603 | 3 | HAI 48603 | 3 |
| | HAI 48604 | 4 | HAI 48604 | 4 |
| | | | | |
| Wide Neck | HAI 60702 | 2 | HAI 60702 | 2 |
| | HAI 60704 | 4 | HAI 60704 | 4 |
| | HAI 60706 | 6 | HAI 60706 | 6 |
# Solid Abutment
| | Subject Device | | | Predicate Device (K171185) | | |
|--------------|----------------|---------|----------|----------------------------|---------|----------|
| Sizes | Product Codes | Heights | Diameter | Product Code | Heights | Diameter |
| Mini/Regular | SAIS 48354 | 4 | 4.8 | SAIS 48354 | 4 | 4.8 |
| | SAIS 48355 | 5.5 | | SAIS 48355 | 5.5 | |
| | SAIS 48357 | 7 | | SAIS 48357 | 7 | |
# Wild Solid Abutment
| Sizes | Subject Device | | | Predicate Device (K171185) | | |
|--------------|----------------|---------|----------|----------------------------|---------|----------|
| | Product Codes | Heights | Diameter | Product Code | Heights | Diameter |
| Mini/Regular | SAIS 48434 | 4 | 4.8 | SAIS 48434 | 4 | 4.8 |
| | SAIS 48435 | 5.5 | | SAIS 48435 | 5.5 | |
| | SAIS 48437 | 7 | | SAIS 48437 | 7 | |
| Wide Neck | SAIS 604EW | 4 | 6.0 | SAIS 604EW | 4 | 6.0 |
| | SAIS 605EW | 5.5 | | SAIS 605EW | 5.5 | |
| | SAIS 607EW | 7 | | SAIS 607EW | 7 | |
Cemented Abutment
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Image /page/7/Picture/0 description: The image shows the logo for Provision Consulting Group. The logo features a stylized bird made of green leaves on the left side. To the right of the bird is the text "PROVISION" in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font below it.
| | Subject Device | | | Predicate Device (K171185) | | |
|-----------|----------------|---------|----------|----------------------------|---------|----------|
| Sizes | Product Codes | Heights | Diameter | Product Code | Heights | Diameter |
| Mini | SAIT 40434 | 4 | 4.8 | SAIT 40434 | 4 | 4.8 |
| | SAIT 40435 | 5.5 | | SAIT 40435 | 5.5 | |
| | SAIT 40437 | 7 | | SAIT 40437 | 7 | |
| Regular | SAITB 40434 | 4 | 4.8 | SAITB 40434 | 4 | 4.8 |
| | SAITB 40435 | 5.5 | | SAITB 40435 | 5.5 | |
| | SAITB 40437 | 7 | | SAITB 40437 | 7 | |
| Wide Neck | SAITB 604EW | 4 | 6.0 | SAITB 604EW | 4 | 6.0 |
| | SAITB 605EW | 5.5 | | SAITB 605EW | 5.5 | |
| | SAITB 607EW | 7 | | SAITB 607EW | 7 | |
# COM OCTA PLUS Abutment
| | Subject Device | | | Predicate Device (K171185) | | |
|---------|----------------|------|----------|----------------------------|---------|----------|
| Sizes | Product Codes | Cuff | Diameter | Product Code | Heights | Diameter |
| Regular | SAITB 4826C | 2 | 4.8 | SAITB 4826C | 2 | 4.8 |
| | SAITB 4846C | 4 | | SAITB 4846C | 4 | |
# Substantial Equivalence Discussion
The subject device, IR SLA Type Implant System has a substantially equivalent intended use as the identified predicate (K171185). Both are used for mandible and maxilla endosseous dental implant and accessories. The IR SLA Type Implant System has the same basic technology as the predicate device in that they all designed, manufactured and tested in accordance with FDA's Class II Special Controls Guidance Document Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments. The subject and predicate devices are identical in size and material except for surface treatment. When compared with predicate devices, no new questions of substantially equivalence have been raised for the IR SLA Type Implant System.
S.L.A. surface is formed by undergoing the process of sandblasting with smaller than 50μm HA (Hydroxy Apa- tite) particles to roughen the machined surface and to form many macropores. After sand blasting and acid etching is done to increase B.I.C (Bone-Implant Contact) and promote cell's activity. With this process, the typical treatment period can be shortened and the patients will be more satisfied with the result.
# Non-Clinical Testing
The subject device was tested to evaluate its performance as below.
- Sterilization validation testing for sterile devices (fixtures) has been performed in ● accordance with ISO 11137, ISO 11737-1 & ISO 11737-2 for gamma sterilization
- Steam sterilization validation for non-sterile devices (abutments) has been performed in ● accordance with ISO 17665-1 and 17665-2.
- Surface characteristics test report Chemical and SEM image analysis have been ● performed to verify that there is no residual after SLA treatment on the fixtures.
- Cytotoxicity test performed according to ISO 10993-5:2009
- Sensitization test performed according to ISO 10993-10:2010 ●
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Image /page/8/Picture/1 description: The image shows the logo for Provision Consulting Group. The logo features a stylized green bird with outstretched wings on the left. To the right of the bird, the word "PROVISION" is written in a bold, sans-serif font, with the words "CONSULTING GROUP" in a smaller font below it.
- LAL Endotoxin lot release testing according to USP <85>
- Shelf-life testing performed according to ISO 11607
Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests has met the standard, and proved the substantial equivalence with the predicate device. Non-clinical testing consisted of a performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The result of the non-clinical testing demonstrates that the subject device is substantially equivalent to the predicate device.
#### Conclusion
The subject device and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium and have the similar surface treatments.
Overall, the IR SLA Type Implant System has the following similarities to the predicate devices:
- has the same intended use
- uses the same operating principle ●
- incorporates the same basic design ●
- incorporates the same material
Based on the similarities, we conclude that the IR SLA Type Implant System is substantially equivalent to the predicate device.
