(176 days)
SAVE GBR is a metal device intended for use with a dental implant to stabilize and support of bone graft in dentoalveolar bony defect sites.
The SAVE GBR consists of Healing Cap, Cover Cap and Spacer. The SAVE GBR are manufactured by Ti-6A1-4V ELI and used with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
The subject device is compatible with the OssBuilder membrane cleared in K172354.
The dimension of the device is as below:
| No. | Product | Diameter | Length |
|---|---|---|---|
| 1 | Healing Cap | Ø4.5 and 5.5 | 6.0 and 7.0mm |
| 2 | Cover Cap | Ø4.5 | 4.0mm |
| 3 | Spacer | Ø4.5 | 7.2 and 8.2mm |
The healing cap and cover cap have same functions and uses but have different design and name. The SAVE GBR are removed from the patient after such time when sufficient bone regeneration is done.
I am sorry, but the provided text (K222451_Decision_Letter[1].pdf) does NOT contain information about acceptance criteria, device performance results, sample sizes for test and training sets, expert qualifications, ground truth establishment, or any details related to an AI/ML-driven medical device study.
The document is a 510(k) premarket notification letter from the FDA regarding a dental device called "SAVE GBR." This device is a metal component used with dental implants to stabilize and support bone grafts. The core of this FDA submission is to demonstrate substantial equivalence to already legally marketed predicate devices, not to present performance data from an AI/ML model.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and study details for an AI-driven device based on this input. The document focuses on material composition, dimensions, sterilization, shelf life, and intended use as compared to predicate devices, rather than AI performance metrics.
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Dentis Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K222451
Trade/Device Name: SAVE GBR Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 5, 2023 Received: January 6, 2023
Dear April Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 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 -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)
Device Name SAVE GBR
Indications for Use (Describe)
SAVE GBR is a metal device intended for use with a dental implant to stabilize and support of bone graft in dentoalveolar bony defect sites.
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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510(k) Summary
Submitter
Dentis Co., Ltd. Gyu Ri Kim 99, Seongseoseo-ro, Dalseo-gu Daegu, 42718 Korea Email: kgr1026@dentis.co.kr Tel. +82-53-589-3541 Fax. +82-53-289-7922
Device Information
- . Trade Name: SAVE GBR
- Common Name: GBR System
- Classification Name: Endosseous Dental Abutment ●
- . Product Code: NHA
- Panel: Dental
- Regulation Number: 872.3630
- Device Class: Class II
- Date prepared: 02/07/2023 ●
Predicate Devices:
Primary Predicate K172354, Ossbuilder System by Osstem Implant Co., Ltd
Reference Device K171027, Dentis Dental Implant System by Dentis Co., Ltd. K181854, Ossbuilder System by Osstem Implant Co., Ltd K140600, SMARTbuilder by Osstem Implant Co., Ltd. K210080, Dentis s-Clean s-Line Mini by Dentis Co., Ltd.
Indication for Use:
SAVE GBR is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
Device Description:
The SAVE GBR consists of Healing Cap, Cover Cap and Spacer. The SAVE GBR are manufactured by Ti-6A1-4V ELI and used with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
The subject device is compatible with the OssBuilder membrane cleared in K172354.
The dimension of the device is as below:
| No. | Product | Diameter | Length |
|---|---|---|---|
| 1 | Healing Cap | Ø4.5 and 5.5 | 6.0 and 7.0mm |
| 2 | Cover Cap | Ø4.5 | 4.0mm |
| 3 | Spacer | Ø4.5 | 7.2 and 8.2mm |
Official Correspondent
Withus Group Inc. April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122
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The healing cap and cover cap have same functions and uses but have different design and name. The SAVE GBR are removed from the patient after such time when sufficient bone regeneration is done. The compatible fixture with the subject device is as below.
| No. | Trade Name | Product Name | Fixture Size | K number |
|---|---|---|---|---|
| 1 | s-Clean SQ-SL ImplantSystem Regular | s-Clean SQ-SL Fixture | Ø5.2 x 7.0, 7.5, 9.5,11.5 and 13.5 | K210132 |
Summaries of Technology Characteristics
The subject device is substantially equivalent to the current cleared devices. They are substantially equivalent in intended use, material and product spec as diameter and length. Comparison demonstrating Substantial Equivalence follows:
| 1. Healing Cap | |||
|---|---|---|---|
| Subject Device | Primary Predicate | Reference Device | |
| Applicant | Dentis Co., Ltd. | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| Trade Name | SAVE GBR | Ossbuilder System | Ossbuilder System |
| 510(k) No. | K222451 | K172354 | K181854 |
| Classification Name | Endosseous Dental Abutment | Endosseous Dental Abutment | Endosseous Dental Abutment |
| Product Code | NHA | JEY, NHA | DZL, NHA |
| Class | Class II | Class II | Class II |
| Description | Image: Subject Device | Image: Primary Predicate | Image: Reference Device |
| Material | Ti-6Al-4V ELI (ASTM F136) | Pure Titanium (ASTM F67) | Ti-6Al-4V ELI (ASTM F136) |
| Diameter | Ø4.5 and Ø5.5 | Ø4.0 and Ø5.0 | Ø4.0 and Ø5.0 |
| Length (mm) | 6.0 and 7.0mm | 7.0 and 8.0mm | 7.0 and 8.0mm |
| Sterile | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 8 years | 8 years | 8 years |
| Indications For Use/Intended Use | SAVE GBR is a metal deviceintended for use with a dentalimplant to stabilize andsupport of bone graft in dento-alveolar bony defect sites. | OssBuilder System is a metaldevice intended for use with adental implant to stabilize andsupport of bone graft indento-alveolar bony defectsites. | OssBuilder System is a metaldevice intended for use with adental implant to stabilize andsupport of bone graft indento-alveolar bony defectsites. |
| Features | Healing Cap is used withinternal type of anchor. | Healing Cap is used withinternal type of anchor. | Healing Cap is used withinternal type of anchor. |
| Principles of operation | Used with non-resorbablemembrane for boneregeneration | Used with non-resorbablemembrane for boneregeneration | Used with non-resorbablemembrane for boneregeneration |
| SubstantialEquivalenceComparison | The subject healing cap is substantially equivalent in designs, material, indications,sterilization, shelf life, compatible membrane, and technological characteristics with theprimary device (K172354). The difference between the subject and primary predicate ismaterial. To support the different material, K181854 was added which is Ti-6Al-4V ELI(ASTM F136). Therefore, the subject device is substantial equivalent. |
- Healing Cap
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- Cover Cap
| Subject Device | Primary Device | |
|---|---|---|
| Applicant | Dentis Co., Ltd. | Osstem Implant Co., Ltd |
| Trade Name | SAVE GBR | Ossbuilder System |
| 510(k) No. | K222451 | K172354 |
| Classification Name | Endosseous Dental Abutment | Endosseous Dental Abutment |
| Product Code | NHA | JEY, NHA |
| Class | Class II | Class II |
| Description | Image: T shaped device | |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Diameter | Ø4.5 | Ø4.0 |
| Length (mm) | 4.0mm | 4.3mm |
| Sterile | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 8 years | 8 years |
| Indications For Use/Intended Use | SAVE GBR is a metal device intended for usewith a dental implant to stabilize and supportof bone graft in dento-alveolar bony defectsites. | OssBuilder System is a metal device intendedfor use with a dental implant to stabilize andsupport of bone graft in dento-alveolar bonydefect sites. |
| Feature | The Cover Cap is used with internal type ofAnchor. | The Cover Cap is used with internal type ofanchor |
| Principles of operation | Used with non-resorbable membrane for boneregeneration | Used with non-resorbable membrane for boneregeneration |
| SubstantialEquivalenceComparison | The subject cover cap is substantially equivalent in designs, material, indications,sterilization, shelf life, compatible membrane, and technological characteristics with theprimary predicate (K172354). The difference between the subject and primary predicate isdimension. The difference of diameter and length is not important to affect the function ofsafety. Therefore, the subject device is substantial equivalent. |
3. Spacer
| Subject Device | Primary Device | Reference Device | |
|---|---|---|---|
| Applicant | Dentis Co., Ltd. | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd |
| Trade Name | SAVE GBR | Ossbuilder System | Ossbuilder System |
| 510(k) No. | K222451 | K172354 | K140600 |
| Classification Name | Endosseous Dental Abutment | Endosseous Dental Abutment | Endosseous Dental Abutment |
| Product Code | NHA | JEY, NHA | NHA |
| Class | Class II | Class II | Class II |
| Description | Image: Subject Device | Image: Primary Device | Image: Reference Device |
| Material | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) | Ti-6Al-4V ELI (ASTM F136) |
| Diameter | Ø4.5 | Ø3.1~5.0 | Ø3.2~5.1 |
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| Length (mm) | 7.2 and 8.2mm | 4.45~9.5 | 7.0~15 |
|---|---|---|---|
| Sterile | Gamma Sterilization | Gamma Sterilization | Gamma Sterilization |
| Shelf Life | 8 years | 8 years | 8 years |
| Indications For Use/Intended Use | SAVE GBR is a metal deviceintended for use with a dentalimplant to stabilize andsupport of bone graft indento-alveolar bony defectsites. | OssBuilder System is a metaldevice intended for use with adental implant to stabilize andsupport of bone graft in dento-alveolar bony defect sites. | SMART Builder System is ametal device intended for usewith a dental implant tostabilize and support of bonegraft in dento-alveolar bonydefect sites. |
| Feature | The Spacer is external type ofanchor | The OB Anchor is internal typeof anchor | The SB Anchor is externaltype of anchor |
| Principles of operation | Used with non-resorbablemembrane for boneregeneration | Used with non-resorbablemembrane for boneregeneration | Used with non-resorbablemembrane (K120951) forbone regeneration |
| SubstantialEquivalenceComparison | The subject spacer is substantially equivalent in general design, dimensions, material,indications, sterilization, shelf life, compatible membrane, and technological characteristicswith the primary predicate (K172354). The difference between the subject and primarypredicate is design, especially head screw shape. To support this discrepancy, K140600 wasadded, which has the similar shape of the device. Therefore, the subject device is substantialequivalent. |
Non-Clinical Testing
Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.
Sterilization and Shelf Life:
The sterilization and shelf life test were performed on predicate healing abutment, K171027 and can be leveraged for subject device since both devices have the same material, sterilization method, packaging method, and manufacturing process as the subject device according to ISO11137-1, ISO11137-2 and ISO11737-3.
Bacterial Endotoxin Test according to ANSI/AAMI ST72:2011, USP <161>, and USP <85> for subject device was referenced in K210080.
Since endotoxin testing cannot be conducted on every batch in our company, alternative to batch testing was chosen with the sampling plan used for the in-process testing and/or finished product release, as recommended in the FDA guidance, Pyrogen and Endotoxins Testing: Questions and Answers".
Reverse Engineering
The pores of the Osstem non-resorbable membranes (K172354) which attach to the abutment were measured and compared to the diameters of the subject device in order to demonstrate compatibility.
Biocompatibility Evaluation:
Biocompatibility tests according to ISO 10993-1 performed on the abutments of K210080 can be leveraged for the subject device because both devices have same material and manufacturing process.
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MR Environment Condition:
Non-clinical worst-case MRI review was performed to evaluate the GBR System in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. " Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testing and Evaluation 49.2 (2019): 783-795), based on the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws) and material composition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including magnetically induced displacement force and torque
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 SAVE GBR is substantially equivalent to the predicate devices as herein.
§ 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.)