(451 days)
No
The summary describes a mechanical device made of titanium for stabilizing bone regeneration materials. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on material properties and mechanical strength.
Yes
The device is used for bone regeneration in the oral cavity, which directly treats a medical condition.
No
This device, the Guided Bone Regeneration (GBR) System, is described as being used to "stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration." This is an active treatment or surgical function, not a diagnostic one. Diagnostic devices are used to identify a disease or condition.
No
The device description explicitly states the materials used (Pure Titanium Grade 4) and describes physical components (stabilize and fix bone filling materials and/or barrier membranes), indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to stabilize and fix bone filling materials and/or barrier membranes for bone regeneration in the oral cavity. This is a surgical/implantable function, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as a system made of titanium, used for stabilization and fixation. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on mechanical strength, biocompatibility, sterilization, and MRI compatibility, which are typical for surgical implants, not IVDs.
- Predicate Devices: The predicate devices listed (Straumann GBR System, Bone Tack, Bone Screw, Tenting Screw) are all surgical devices used in bone regeneration procedures.
In summary, the function and characteristics of this device clearly indicate it is a surgical device used for bone regeneration, not an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
Product codes
DZL
Device Description
The GBR System consists of screws used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
MATERIALS:
Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Conducted
Substantial equivalence to the predicate devices was determined by the following tests:
- The product is manufactured from pure titanium (Grade 1641) raw material in accordance with EN 1642, TS EN ISO 19023, ISO 5832-2 and ASTM F67-13 Standard.
- Our biocompatibility assessment is leveraged from our FDA approved application K231100. The devices in K231100 are made of the same materials and underwent the same manufacturing processes compared to the subject device.
- Our Insertion Torque, Fracture Torque, Pull-out tests, which we had performed in neutral laboratories for the mechanical strength of our products, were carried out in accordance with TS EN ISO 19023 and ASTM F543-23 Standards.
- Our non-sterile products should be sterilized with Autoclave before use by the users in accordance with the parameters specified in our user manuals.
- The autoclave sterilization method declared by us has been validated in accordance with EN 17665-1 Standard. Our device has been verified by sterility tests.
MRI Compatibility:
Rationale for relying on the Woods et al. Article
Non-clinical worst-case MRI review was performed to evaluate the Proimtech devices 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. The 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. The GBR System is labeled as MR conditional.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4880 Intraosseous fixation screw or wire.
(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.
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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 03, 2025
Proimtech Saglik Urunleri Anonim Sirketi Hakan Cevik Official Correspondent Dudullu OSB Mahallesi Imes Sanayi Sitesi E Blok 501. Sokak N o:25 Dudullu OSB Mahallesi Imes Sanayi Sitesi C Blok 305. Istanbul, UMRANIYE 34775 TURKEY
Re: K233419
Trade/Device Name: GBR System Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: December 9, 2024 Received: December 9, 2024
Dear Hakan Cevik:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Sherrill Lathrop Blitzer
for Andrew 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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233419
Device Name GBR System
Indications for Use (Describe)
The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
| 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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4
510(k) Summary 510k number: K233419 GBR System Proimtech Saglik Urunleri Anonim Sirketi
| Company Name | : | Proimtech Saglik Urunleri A.S. |
|---|---|---|
| Authorised Person / Title | : | Hakan Çevik / General Manager |
| Address-1 | : | Dudullu OSB Mahallesi Imes 305 Sokak C Blok No:3 PK:34775 |
| Umraniye / İstanbul | ||
| Address-2 | : | Dudullu OSB Mahallesi Imes 501 Sokak E Blok No:25 PK:34775 |
| Umraniye / İstanbul | ||
| Phone | : | +90 (216) 999 5041-44 |
| Web/Mail | : | www.bilimplant.com / info@bilimplant.com |
| Official Contact | : Hakan Cevik, General Manager of Proimtech Saglik Urunleri Anonim Sirket |
|---|---|
| Phone Number | : +90 535 355 51 00 |
| : hakancevik@bilimplant.com |
DEVICE INFORMATION
Preparation Date: December 31, 2024
Device Trade Name: GBR System
Common Name: GBR Kit
Classification Name: Intraosseous fixation screw or wire (21 CFR 872.4880)
Device Class: II
Product Code: DZL
Regulation Number: 872.4880
Review Panel: Dental
5
INDICATION FOR USE
The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
DEVICE DESCRIPTION
Image /page/5/Figure/3 description: The image shows three different types of screws and their functions. The first screw is silver and is used for block bone graft fixation. The second screw is purple and stabilizes the graft particles by creating a tent effect under the membrane. The third screw is blue and fixes the membrane.
MATERIALS:
Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.
Non-Clinical Tests Conducted
Substantial equivalence to the predicate devices was determined by the following tests:
-
The product is manufactured from pure titanium (Grade 1641) raw material in accordance with EN 1642, TS EN ISO 19023, ISO 5832-2 and ASTM F67-13 Standard.
-
Our biocompatibility assessment is leveraged from our FDA approved application K231100. The devices in K231100 are made of the same materials and underwent the same manufacturing processes compared to the subject device.
-
Our Insertion Torque, Fracture Torque, Pull-out tests, which we had performed in neutral laboratories for the mechanical strength of our products, were carried out in accordance with TS EN ISO 19023 and ASTM F543-23 Standards.
-
Our non-sterile products should be sterilized with Autoclave before use by the users in accordance with the parameters specified in our user manuals.
-
The autoclave sterilization method declared by us has been validated in accordance with EN 17665-1 Standard. Our device has been verified by sterility tests.
6
MRI Compatibility:
Rationale for relying on the Woods et al. Article
Non-clinical worst-case MRI review was performed to evaluate the Proimtech devices 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. The 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. The GBR System is labeled as MR conditional.
Legally Marketed Device to Which
Claim Substantial Equivalence:
For primary device GBR System: K011698; Straumann GBR System Straumann USA
For reference device GBR System: K182881; Bone Tack, OSSTEM Implant Co., Ltd.
For reference device GBR System: K182881; Bone Screw, OSSTEM Implant Co., Ltd
For reference device GBR System: K161857; Tenting Screw, Salvin Dental
7
SUMMARIES OF TECHNOLOGICAL CHARACTERISTICS & SUBSTANTIAL EQUIVALENCE DISCUSSION
8
| Technological
Characteristics | Subject Device
GBR System | Primary Predicate Device
Straumann GBR System | Reference Device
Bone Tack | Reference Device
Tenting Screw | Reference Device
Bone Screw |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K233419 | K011698 | K182881 | K161857 | K182881 |
| Manufacturer | Proimtech Saglik Urunleri A.S | Straumann USA | Osstem Implant Co.,
Ltd. | Salvin Dental | Osstem Implant Co.,
Ltd. |
| Product Code | DZL | JEY and DZL | DZL | DZL | DZL |
| Indications for Use | The Guided Bone Regeneration (GBR)
System is used to stabilize and fix
bone grafts, bone filling materials
and/or barrier membranes used for
bone regeneration in the oral cavity. | 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
unsuitable sites. | It is indicated for use
to stabilize and
support bone graft
and/or fractured
bone segments with
or without bone
plates or titanium
mesh in oral and
maxillofacial site
defects. | The Salvin Tenting Scr
ew is used to stabilize
, fixate, and/or suppo
rt bone grafts, bone fi
lling materials and /o
r barrier membranes
used for regeneration
of bone in the oral ca
vity. | Bone Screw is used
to stabilize and fixate
bone grafts, bone
filling material,
and/or barrier
membranes used for
regeneration of bone
in the oral cavity |
| Design | Image: Blue screw | Image: Purple screw | Image: Yellow screw | Image: Silver screw | Image: Two silver screws |
| Material | Titanium (Ti Grade 4, ASTM F67) | Titanium (Ti Grade 4, ASTM
F67) | Titanium Alloy (Ti-
6Al-4V, ASTM F136) | Ti-6Al-
4V ELI (ASTM F136) | Titanium Alloy (Ti-
6Al-4V, ASTM F136) |
| Diameter | 1
1.2
1.5
2 | 1.2 mm
1.5 mm | 2.5 mm | 1.5 | 1.4 mm
1.95 mm |
| Length | Ø13.7 mm
Ø1.26 mm
Ø1.28 mm
Ø1.210 mm
Ø1.212 mm
Ø1.214 mm
Ø1.56 mm
Ø1.57 mm
Ø1.58 mm
Ø1.59 mm
Ø1.510 mm
Ø1.511 mm
Ø1.512 mm
Ø25 mm
Ø26 mm
Ø27 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 | 3.0 mm | 7 mm
8 mm
9 mm | Ø1.4:
4.0 mm
6.0 mm
8.0 mm
Ø1.95:
8.0 mm
10.0 mm
12.0 mm
14.0 mm
16.0 mm |
| Single Use | Yes | Yes | Yes | Yes | Yes |
| Sterilization | Non-sterile | Non-sterile | Sterile | Non-sterile | Sterile |
| Principle of Operation | The function of proposed device is
used in application for fixating or
stabilizing barrier membranes in GBR | The function of predicate
devices is used in application
for maintaining the relative
position of and/or bone grafts
in reconstruction of maxillary
and/or mandibular areas | The function of
proposed device is
used in application
for fixating or
stabilizing barrier
membranes in GBR | The Salvin Tenting Scr
ew System is a set of
bone screws and inst
rumentation. The sys
tem consists of a set
of screws (one diame
ter and three lengths
) and the driver used
to implant these scre
ws. The devices are d
elivered non-
sterile. The screws ar
e made from titaniu
m alloy (Ti-
6Al4V ELI), as describ
ed by ASTM F136. | The function of
proposed devices is
used in application
for maintaining the
relative position of
and/or bone grafts in
reconstruction of
maxillary and/or
mandibular areas |
9
10
Similarities
The device has similar characteristics compared to the predicate and reference devices in the following respects. Indication for use, design, sterilization, disposable and operating principle.
Difference
The material, diameter and length dimensions of the device in question are slightly different from the the predicate and reference devices. However, as a result of the insertion torque and pull-out tests, it was determined that there was no significant difference in product performance and that this difference did not affect the substantial equivalence.
Discussion
On the basis of the above discussion, it is concluded that the device in question is substantially equivalent to the predicate and reference devices.