Who is the manufacturer of GBR system?

Surgident filed the 510(k) submission for GBR system (K170697).

What is the FDA product code for GBR system?

JEY. It is classified under 21 CFR 872.4760 as a Class 2 device in the Dental panel.

What is the regulatory pathway for GBR system?

510(k) clearance (submission type: Traditional).

What are the predicate devices for GBR system?

TriStar Bone Graft Fixation System (K141764); Jeil Bone Fixation system (K050669); Straumann GBR system (K011698).

Who can help prepare an FDA 510(k) submission like GBR system?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GBR system

K170697 · Surgident · JEY · May 24, 2018 · Dental

Device Facts

Record ID	K170697
Device Name	GBR system
Applicant	Surgident
Product Code	JEY · Dental
Decision Date	May 24, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4760
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only.

Device Story

GBR System consists of titanium bone screws and plates used for bone fixation surgery in the oral cavity. Screws are available in various diameters and lengths with self-drilling/self-tapping or pre-drilling options. Plates are provided in specific thicknesses and dimensions. The device is supplied non-sterile and requires steam sterilization by the clinician prior to use. It is used by dental surgeons to stabilize bone grafts or membranes during guided bone regeneration procedures. The mechanical fixation provided by the screws and plates maintains the position of graft materials, facilitating bone reconstruction. The system is intended for single-patient use.

Clinical Evidence

Bench testing only. Mechanical properties were validated via dimension, pull-out, torsion, tensile, and bending tests in accordance with ASTM F543-17. Biocompatibility was confirmed per ISO 10993-3, 10993-6, 10993-10, and 10993-11. Sterilization parameters were validated per ISO 17665-1:2006 to achieve a SAL of 10^-6.

Technological Characteristics

Materials: Titanium alloy (ASTM F136) for screws; Pure titanium Grade 1 (ASTM F67) for plates. Design: Bone screws (0.85-2.0mm diameter; 3.0-12.0mm length) and plates (0.1mm thickness). Principle: Mechanical fixation. Sterilization: Steam (gravity displacement or pre-vacuum). Connectivity: None.

Indications for Use

Indicated for stabilization and fixation of bone grafts, bone filling materials, and/or barrier membranes for guided bone/tissue regeneration in the oral cavity. For single patient use.

Regulatory Classification

Identification

A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.

Predicate Devices

TriStar Bone Graft Fixation System (K141764)
Jeil Bone Fixation system (K050669)
Straumann GBR system (K011698)

Related Devices

K143730 — GBR System · Jeil Medical Corporation · Jun 10, 2015
K233419 — GBR System · Proimtech Saglik Urunleri Anonim Sirketi · Jan 3, 2025
K050669 — JEIL BONE FIXATION SYSTEM · Jeil Medical Corporation · May 26, 2005
K011698 — STRAUMANN GBR SYSTEM · Institut Straumann AG · Aug 23, 2001
K222367 — SAVE GBR · Dentis Co., Ltd. · Mar 23, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. Surgident % Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213 May 24, 2018 Re: K170697 Trade/Device Name: GBR System Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: Class II Product Code: JEY Dated: April 27, 2018 Received: April 27, 2018 Dear Peter 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. 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 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 (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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, # Mary S. Runner -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) K170697 Device Name GBR System Indications for Use (Describe) The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary #### 1. Applicant - 1) Company : SURGIDENT Co., Ltd. - 2) Address : #209~210, Woolim Lion's Valley, 27, Dunchon-daero 457beon-gil, Jungwongu, Seongnam-si, Gyeonggi-do, 13219, Korea - 3) Tel : 82-31-737-2875 - 4) Fax : 82-31-737-2876 - 5) President of company : Duck-su Hur - 6) Contact person : Peter Chung - 7) Contact Person Telephone : 412-687-3976 - 8) Contact Person E-mail : peterchung210@gmail.com - 9) Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA - 10) Date : May 21, 2018 #### 2. Device Information - 1) Trade Name : GBR System - 2) Common Name : Bone Fixation System - 3) Classification Name : Bone Plate - 4) Product Code : JEY - 5) Subsequent Product Code: DZL - 6) Regulation Number : 872.4760 - 7) Class of device : Class II - 8) Panel : Dental #### 3. The legally marketed device to which we are claiming equivalence : Primary Predicate : K141764, TriStar Bone Graft Fixation Predicate Devices: System / Impladent Ltd. Reference Predicate : K050669, Jeil Bone Fixation system / Jeil Medical Corporation Reference Predicate : K011698, Straumann GBR system / Straumann #### 4. Device description and technological characteristics : The GBR System is comprised of bone screws and bone plates that are used for bone fixation surgery. The bone screws and plates are not reusable. The bone screws are composed of the titanium alloy (ASTM F136) and the bone plates are composed of the pure titanium (ASTM F67 Grade 1). The screws are offered in following range; diameter (0.85, 1.4, 2.0 mm) and length (3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0 mm). Also, the tip of screw has single type; the self-drilling and self-tapping available type and the type that require the pre-drilling (Surgeon's option). The bone plate is offered in 0.1 mm thickness and in length 22 mm x 15 mm, 36 mm x 22 mm and 44 mm x 44 mm. Each device is {4}------------------------------------------------ provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended. #### 5. Indication for Use: The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only. #### 6. Non-clinical Performance Testing: #### Mechanical properties Bench testing was conducted with the predicate device to confirm that the GBR System has equivalent physical properties through the dimension test, pull out, torsion, tensile and bending tests in accordance with ASTM F543-17. Mechanical properties from bench tests of GBR System found substantially equivalent to the predicate device. #### Biocompatibility testing The test results and analysis found that the dental implant material and manufacturing processes were biocompatible according to ISO 10993-3, 10993-6, 10993-10 and 10993-11. #### Sterilization Testing Steam sterilization parameters were validated for 2 methods: gravity displacement and pre-vacuum steam sterilization. The studies were conducted in accordance with ISO 17665-1:2006 and demonstrated a SAL of 10°. | | Subject Device | Primary Predicate Device | Reference Predicate Device | Similarity/Difference Discussion | |-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K170697 | K050669 | K011698 | - | | Device Name | GBR System | Jeil Bone Fixation System | Straumann GBR System | - | | Manufacturer | SURGIDENT Co., Ltd. | Jeil Medical Corp. | Straumann USA | - | | Indications for Use | The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only. | The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only. | The Straumann Guided Bone Regeneration (GBR) System is used to stabilize and fixate bone grafts, bone filling materials, and/or barrier membranes used for regeneration of bone in the oral cavity. The GBR technique can make it possible for the placement of dental implants in previously | Similarity | | | Subject Device | Primary Predicate Device | Reference Predicate Device | Similarity/Difference Discussion | | Components | Screws | Screws | Screws | Similarity | | Material | Titanium Alloy (Ti- 6Al-4V) (ASTM F 136) | Titanium Alloy (Ti- 6Al-4V) (ASTM F 136) | Pure Titanium (ASTM F 67) | Similarity | | Shape | Image: Subject Device Screw | Image: Primary Predicate Device Screw | Image: Reference Predicate Device Screw | Similarity | | Screw Type | Self-tapping Screw Self-drilling Screw | Self-tapping Screw Self-drilling Screw | Self-tapping Screw Self-drilling Screw | Similarity | | Screw Diameter | 0.85 mm 1.4 mm 1.6 mm 2.0 mm | 1.4 mm 1.6 mm 2.0 mm | 1.2 mm 1.5 mm | Different: The screw diameter and length range of the subject device is within the range of the predicate devices. | | Screw Length | 3.0 mm 3.5 mm 4.0 mm 5.0 mm 6.0 mm 8.0 mm 10.0 mm 12.0 mm | 3.0 mm 4.0 mm 6.0 mm 8.0 mm 10.0 mm 12.0 mm 16.0 mm | 3.0 mm 4.0 mm 5.0 mm 7.0 mm 8.0 mm 9.0 mm 10.0 mm 12.0 mm 14.0 mm | There is an additions diameter in the subject device comparing to the primary predicate device. However, the difference in diameter is minor; it is not introducing significantly different design, and the performance test results supported that this difference does not raise an issue in performance. | | Surface Casting | Anodizing | Anodizing | Anodizing | Similarity | | Single Use | yes | yes | yes | Similarity | | Sterilization method | Non-sterile, Steam sterilization prior to use | Non-sterile, Steam sterilization prior to use | Non-sterile, Steam sterilization prior to use | Similarity | | Shelf-life | 5 years | Unknown | Unknown | Similarity | | Biocompatibility | Biocompatible according to ISO 10993-1, ASTM F 136 | Biocompatible according to ISO 10993-1, ASTM F 136 | Biocompatible according to ISO 10993-1 and ASTM F 67 | Similarity | | Principle of Operation | The function of GBR System is used | The function of GBR System is used | The function of GBR System is used | Similarity | | Subject Device | Primary Predicate Device | Reference Predicate Device | Similarity/Difference Discussion | | | in applications for maintaining the relative position of and/or bone grafts in reconstruction of maxillary and/or mandibular areas. | in applications for maintaining the relative position of and/or bone grafts in reconstruction of maxillary and/or mandibular areas. | in applications for maintaining the relative position of and/or bone grafts in reconstruction of maxillary and/or mandibular areas. | | | ### 7. Substantial Equivalence to Predicate Devices Table - Screws {5}------------------------------------------------ {6}------------------------------------------------ ## 8. Substantial Equivalence to Predicate Devices Table - Mesh | | Subject Device | Primary Predicate Device | Similarity/Difference Discussion | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K170697 | K141764 | - | | Device Name | GBR System | TriStar Bone Graft Fixation System | - | | Manufacturer | SURGIDENT Co., Ltd. | Impladent Ltd. | - | | Indications for Use | The device is intended for use in stabilizing and fixating bone grafts, bone filling material and/or barrier membranes used for guided bone/tissue regeneration in the oral cavity. Single patient use only. | The TriStar Bone Graft Fixation System is indicated for stabilization and fixation of bone grafts, bone blocks, bone filling materials, and / or barrier membranes used to regenerate bone in the oral cavity. | Difference : Indication for use of the subject device is slightly different from the predicate in phrase but fundamental indication is similar. | | Materials | Grade 1 Titanium (ASTM F67) | Grade 1 Titanium | Similarity | | Shape | Image: Subject Device Shape | Image: Primary Predicate Device Shape | Similarity | | Plate Design | Compression Type | Compression Type | Similarity | | Plate Thickness | 0.1 mm | 0.1 mm | Similarity | | Size of holes | 0.8 mm | 0.8 mm | Similarity | | Hole Shape | "O" shape (circle) | "O" shape (circle) | Similarity | | Dimensions | 22 × 15 mm 36 × 22 mm 44 × 44 mm | 18 × 25 mm 40 × 60 mm | Difference : The plate dimensions range of the subject device is within the range of the predicate devices. | | Single Use | yes | yes | Similarity | | Sterilization method | Non-sterile, Steam sterilization prior | Non-sterile, Steam sterilization prior | Similarity | | | Subject Device | Primary Predicate Device | Similarity/Difference Discussion | | | to use | to use | | | Shelf-life | 5 years | Unknown | Similarity | | Biocompatibility | Biocompatible according to ISO 10993-1 and ASTM F 67 | Biocompatible according to ISO 10993-1 and ASTM F 67 | Similarity | {7}------------------------------------------------ ### 9. 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, SURGIDENT Co., Ltd. concludes that the GBR System is substantially equivalent to the predicated devices as herein.