(175 days)
No
The summary describes a physical, pre-formed titanium membrane for bone grafting support and stabilization, with no mention of software, algorithms, or any AI/ML related terms or concepts.
No
The device is described as a non-resorbable membrane made of titanium metal intended to stabilize and support bone graft, which does not inherently qualify it as a therapeutic device. It is a structural support rather than a device that delivers therapy or treatment for a disease or condition.
No
The device description indicates it is a "metal (Non-resorbable membrane) device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites." It also describes it as a "Customized 3D Pre-Formed Titanium Membrane" that stabilizes and supports bone graft. These functions are therapeutic/supportive, not diagnostic.
No
The device description explicitly states it is a "metal (Non-resorbable membrane) device" made of "titanium metal," indicating it is a physical hardware 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 clearly states the device is for stabilizing and supporting bone graft in dento-alveolar bony defect sites, which is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical, non-resorbable titanium membrane used for bone grafting support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The SMARTbuilder System (SB1) is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
Product codes (comma separated list FDA assigned to the subject device)
JEY
Device Description
Customized 3D Pre-Formed Titanium Membrane. SMARTbuilder System (SB1) is the nonabsorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity.
The SMARTbuilder System (SB1) is made of pure titanium metal and supplied sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity, dento-alveolar bony defect sites
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)
No clinical studies are submitted
Biocompatibility evaluation for SMARTbuilder System is not considered because SMARTbuilder System (SB1) has same material and manufacture process with SMARTbuilder System, predicate device and SMARTbuilder System (SB1) material, Pure Titanium Grade 2 (ASTM F67) has been generally and widely used as a dental material such as implant for a long time
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 872.4760 Bone plate.
(a)
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.(b)
Classification. Class II.
0
OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: February 26, 2013
- Company and Correspondent making the submission:
-
Submitter's Name :
-
Address :
-
Contact :
-
Phone:
- Device :
Trade or (Proprietary) Name : Classification Name :
SMARTbuilder System (SB1) Bone Plate 21CFR872.4760 Class II JEY
OSSTEM Implant Co., Ltd.
Mr. Hee Kwon Son
+82 51 850 2575
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea
SEP 1 8 2013
3. Predicate Device:
The SMARTbuilder System, OSSTEM IMPLANT Co., Ltd., K120951
4. Description:
Customized 3D Pre-Formed Titanium Membrane. SMARTbuilder System (SB1) is the nonabsorbable membrane that is made of titanium metal to stabilize and support of bone graft after bone transplantation at the area having autogenous bone deficiency in the oral cavity.
| Dimensions (mm) | ||
|---|---|---|
| SMARTbuilder SB2 | ||
| BW | BL | P(Proximal): 5.0, 6.0, 7.0 |
| BW(Buccal width): 9.0, 12.0 | ||
| BD(Buccal Distance): 5.5 | ||
| BL(Buccal Length): 7, 9 |
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
1
SSTEM®
OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
Image /page/1/Figure/3 description: The image shows the SMARTbuilder SB1 scallop shape with measurements. The proximal measurement (P) is 7.0, 10.0, and 12.0. The lingual distance (LD) is 5.0, 5.5, and 6.5, while the buccal distance (BD) is 5.0, 5.5, and 6.5. The buccal length (BL) is 3.0 and 5.0.
The SMARTbuilder System (SB1) is made of pure titanium metal and supplied sterile.
The SMARTbuilder System (SB1) is used with GS3 System (K091208) of OSSTEM Implant Co., Ltd. and US.SS.GS System (K073247) of OSSTEM Implant Co., Ltd.
The SMARTbuilder is substantially equivalent in design, function and intended use to the SMARTbuilder System, SMARTbuilder (K120951) of OSSTEM Implant Co., Ltd.
| Proposed Device | Predicate devices | ||
|---|---|---|---|
| SMARTbuilder (SB1) | SMARTbuilder (SB2) | ||
| 510(K) | - | K120951 | |
| Design | Image: Scallop shape with dimension D | Image: Design with dimension D | |
| Intended | |||
| use | SMARTbuilder is a metal device intended | ||
| for use with a dental implant to stabilize and | |||
| support of bone graft in dento-alveolar bony | |||
| defect sites. | SMARTbuilder is a metal device intended for | ||
| use with a dental implant to stabilize and | |||
| support of bone graft in dento-alveolar bony | |||
| defect sites. | |||
| Material of | |||
| Fixture | Pure Titanium Grade 2 (ASTM F67) | Pure Titanium Grade 2 (ASTM F67) | |
| Width (D) | 7, 10, 12 | 8, 9, 10, 12 | |
| Sterilization | Sterilie | Sterilie | |
| Shelf life | 8years | 5years | |
| SE | The SMARTbuilder has same material and indication for use and similar design and | ||
| technological characteristics as the predicate device, such as the SMARTbuilder System |
- Substantial Equivalence Matrix
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
2
OSSTEM Implant Co., Ltd.
OSSTEM® #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com
-
- Indication for use :
The SMARTbuilder System (SB1) is a metal device intended for use with a dental implant to stabilize and support of bone graft in dento-alveolar bony defect sites.
- Indication for use :
-
- Review :
The SMARTbuilder System (SB1) has the same material and indication for use and similar design and technological characteristics as the predicate device.
- Review :
-
- Summary of nonclinical testing
Biocompatibility evaluation for SMARTbuilder System is not considered because SMARTbuilder System (SB1) has same material and manufacture process with SMARTbuilder System, predicate device and SMARTbuilder System (SB1) material, Pure Titanium Grade 2 (ASTM F67) has been generally and widely used as a dental material such as implant for a long time
- Summary of nonclinical testing
-
- Summary of clinical testing No clinical studies are submitted
-
- Conclusion :
Based on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the SMARTbuilder system (SB1) is substantially equivalent to the predicate devices as described herein
QS-QI-505-3(Rev.0)
Letter(8.5 X 11in)
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2013
OSSTEM Implant Company, Limited C/O Mr. Patrick Lim Manager HIOSSEN Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030
Re: K130840
Trade/Device Name: SMARTbuilder System (SB1) Regulation Number: 21 CFR 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: JEY Dated: August 9, 2013 Received: August 20, 2013
Dear Mr. Lim:
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.
4
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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary-S.Runner -S
Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| | OSSTEM Implant Co., Ltd.
#507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea
Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K 130840 |
| Device Name | SMARTbuilder system (SBI) |
| Indication for use | SMARTbuilder System is a metal (Non-resorbable membrane) device
intended for use with a dental implant to stabilize and support of bone
graft in dento-alveolar bony defect sites. |
| Prescription Use | X |
| (Per 21CFR801 Subpart D) | OR Over-The-Counter Use
(Per 21CFR807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen
2013.09.18 08:38:56 -04'00'
Division Sign-Off)
Division of Anesthesiology, General Hospital
Section Control, Dental Devices
| 510(k) Number: | K130840 |
|---|---|
| ---------------- | --------- |
: :
করে বেশন রাজশাহীন ব্যবহার ব্যবহার ব্যবহার করে বাংলাদেশ
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QS-QI-505-2(Rev.0)
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ייני הייני היישובים